Description
On December 19, 2016, FDA published a final rule banning powdered gloves based on the unreasonable and substantial risk of illness or injury to individuals exposed to the powdered gloves (https://www.federalregister.gov/documents/2016/12/19/2016-30382/banned-devices-powdered-surgeons-gloves-powdered-patient-examination-gloves-and-absorbable-powder). This guidance document has not been updated to reflect the ban. FDA is assessing how to revise this guidance to represent our current thinking on medical gloves.
Scope & Applicability
Product Classes
10FDA published a final rule banning powdered gloves based on risk of illness or injury
Direct reference authority for regulatory actions; Devices subject to direct reference authority and 515(b) requirements.; Direct reference authority for high-risk devices
Class I device used for medical activities except surgery.
Gloves requiring bioburden control
Requires maintenance of a design history file
specialty medical gloves requiring specific data for labeling claims
substantiating a powder-free claim in a 510(k) submission; Gloves with residual powder not exceeding 2 mg per glove; Gloves where starch is removed during processing
Device made of natural or synthetic rubber to protect surgical wounds.; Surgeon's gloves that may be lubricated with silicone
Disposable device intended for medical purposes to prevent contamination.
Labeling requirement for chemotherapy use and non-pyrogenic claims
Stakeholders
5Must comply with registration if meeting facility/responsible person definitions
Entity responsible for submitting NDINs
Entity being verified by the importer; The establishment that manufactures, processes, raises, or grows the food.; entity producing food outside the US; entity being verified by the importer; Entity being evaluated and verified by the importer.; The establishment that manufactures or processes food for export to the US.; entity supplying food from outside the United States; The entity producing the food outside the U.S.; entity being verified under FSVP; entity providing food to the importer; en
Party responsible for notifying FDA of HCT/P imports
the glove manufacturer should have a contract with the contract sterilizer; Entity that performs sterilization services for a manufacturer.; Agreement required between the importer and the contract sterilizer.
Regulatory Context
Attributes
10The end point achieved by a sterilizing process.
Physical property monitored during dip line processing
ECN 429 added protein limit to the specification.
Acceptable Quality Level for finished device testing
User safety characteristic specification
Specification for medical gloves
Property of a device that may be changed via established protocols
Quality parameter that must remain unchanged for the policy
Measured in mcg/dm2 for natural rubber latex gloves; Parameter measured during routine production; Characteristic that must be quantified if low protein claims are made
Measurement of powder on finished powder glove in milligrams per dm²
Identified Hazards
Hazards
4Basis for FDA requesting a product recall
Potential for contamination of covered produce; Known or reasonably foreseeable hazards in water
Contamination resulting from inadequate drying
Enclose natural rubber latex gloves to avoid protein contamination
Related CFR Sections (18)
- 21CFR820.40§ 820.40 [Reserved]
- 21CFR820.3§ 820.3 Definitions.
The definitions in ISO 13485 and in Clause 3 of ISO 9000 (incorporated by reference, see § 820.7 ) apply to this part, except as specified in paragraph (b) of this section, and do not affect the meaning of similar terms defined in this title.Read full regulation →
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
- 21CFR807.93§ 807.93 Content and format of a 510(k) statement.
- 21CFR807.92§ 807.92 Content and format of a 510(k) summary.
(a) A 510(k) summary shall be in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence. FDA will accept summaries as well as amendments thereto until such time as FDA issues a determination of substantial equivalence. All 510(k) summaries shall conRead full regulation →
- 21CFR807.100§ 807.100 FDA action on a premarket notification.
(a) After review of a premarket notification, FDA will:Read full regulation →
- 21CFR801.437§ 801.437 User labeling for devices that contain natural rubber.
(a) Data in the Medical Device Reporting System and the scientific literature indicate that some individuals are at risk of severe anaphylactic reactions to natural latex proteins. This labeling regulation is intended to minimize the risk to individuals sensitive to natural latex proteins and protecRead full regulation →
- 21CFR800.20§ 800.20 Patient examination gloves and surgeons' gloves; sample plans and test method for leakage defects; adulteration.
(a) Purpose. The prevalence of human immunodeficiency virus (HIV), which causes acquired immune deficiency syndrome (AIDS), and its risk of transmission in the health care context, have caused the Food and Drug Administration (FDA) to look more closely at the quality control of barrier devices, suchRead full regulation →
- 21CFR801.62§ 801.62 Declaration of net quantity of contents.
(a) The label of an over-the-counter device in package form shall bear a declaration of the net quantity of contents. This shall be expressed in the terms of weight, measure, numerical count, or a combination of numerical count and weight, measure, or size: Provided, That:Read full regulation →
- 21CFR801.15§ 801.15 Medical devices; prominence of required label statements; use of symbols in labeling.
(a) A word, statement, or other information required by or under authority of the act to appear on the label may lack that prominence and conspicuousness required by section 502(c) of the act by reason, among other reasons, of:Read full regulation →
- 21CFR801.61§ 801.61 Statement of identity.
(a) The principal display panel of an over-the-counter device in package form shall bear as one of its principal features a statement of the identity of the commodity.Read full regulation →
- 21CFR807.81§ 807.81 When a premarket notification submission is required.
(a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to § 807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for inRead full regulation →
- 21CFR807.40§ 807.40 Establishment registration and device listing for foreign establishments importing or offering for import devices into the United States.
(a) Any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a device that is imported or offered for import into the United States shall register such establishment and list such devices using the FDA electronic device registraRead full regulation →
- 21CFR880.6250§ 880.6250 Non-powdered patient examination glove.
(a) Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes othRead full regulation →
- 21CFR878.4460§ 878.4460 Non-powdered surgeon's glove.
(a) Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove incluRead full regulation →
- 21CFR801.150§ 801.150 Medical devices; processing, labeling, or repacking.
(a) Except as provided by paragraphs (b) and (c) of this section, a shipment or other delivery of a device which is, in accordance with the practice of the trade, to be processed, labeled, or repacked, in substantial quantity at an establishment other than that where originally processed or packed, Read full regulation →
- 21CFR878.4470§ 878.4470 Surgeon's gloving cream.
(a) Identification. Surgeon's gloving cream is an ointment intended to be used to lubricate the user's hand before putting on a surgeon's glove.Read full regulation →
- 21CFR892.6500§ 892.6500 Personnel protective shield.
(a) Identification. A personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation. This generic type of device may incRead full regulation →
Related Warning Letters (10)
- 2025-12-09
CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
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CGMP/QSR/Medical Devices/Adulterated
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- 2025-10-28
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- 2025-10-28
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- 2025-10-28
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- 2025-10-21
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LEVO AG
- 2025-10-07
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Technological Medical Advancements LLC
- 2025-09-30
Medical Device Reporting/Misbranded
Insung Medical Co. Ltd.
- 2025-09-23
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
The Richline Group, Inc.
- 2025-09-16
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
SeniorLife Technologies, Inc.
See Also (8)
- CPG Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections (Status: Final)
- Device Labeling Guidance #G91-1 (Blue Book Memo) (Status: Final)
- CPG Sec. 310.100 Pacemaker Reuse (Status: Final)
- Immunotoxicity Testing Guidance (Status: Final)
- Postmarket Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Quality Management System Information for Certain Premarket Submission Reviews: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- Suggested Format For IDE Progress Report (Status: Final)
- Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)