Description
U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Devices and Radiological HealthMolecular Biology BranchDivision of Life SciencesOffice of Science and Technology
Scope & Applicability
Product Classes
10FDA published a final rule banning powdered gloves based on unreasonable risk
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.
Example of nonconforming product due to moisture
Requires maintenance of a design history file
suggested format for the submission of a Premarket Notification (510(k)) for surgeon's gloves; Device category under 21 CFR 878.4460; surgeon's gloves are subject to design control requirements; Gloves requiring bioburden control and specific drying air quality; Mentioned in the context of sterilization agreements.; Specific glove type subject to design controls; Subject of ASTM standards for surgical use
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
specialty medical gloves requiring specific data for labeling claims
Subject of the premarket notification format; patient examination gloves are not subject to design controls; Specific glove type subject to leakage testing; Subject of ASTM standards for medical application
Device made of natural or synthetic rubber to protect surgical wounds.; Surgeon's gloves that may be lubricated with silicone
Stakeholders
8Assists FDA in communications with foreign establishments
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
Law places burden of determining quality and compliance upon the U.S. importer
The IOR's name, address, and FEI are required for the WEF request.
External facility performing infectious disease testing or pooling
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.
Must comply with registration if meeting facility/responsible person definitions
Entity responsible for submitting NDINs
Regulatory Context
Attributes
10The end point achieved by a sterilizing process.
Dating requirements for drug products compounded by outsourcing facilities.
Specification limit for residual powder on the device.
ECN 429 added protein limit to the specification.
support the use of the proposed cycle and the desired sterility assurance level
Acceptable Quality Level for finished device testing
The rule classifies most ASRs as Class I devices.
The SAL should be 10⁻⁶ or better for a sterile glove.; Statistical probability of non-sterility
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
Acceptable Quality Level for pinholes in gloves
Identified Hazards
Hazards
5Basis for the ban on powdered gloves
microbiological contamination risk in bulk solution
Mold found in insufficiently dried gloves
Potential for contamination of covered produce; Known or reasonably foreseeable hazards in water
Risk addressed by testing for chemotherapy gloves
Related CFR Sections (16)
- 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 →
- 21CFR801.61§ 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.
- 2025-11-25
CGMP/QSR/Medical Devices/Adulterated
Hong Qiangxing Shenzhen Electronics Limited
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated
Contec Medical Systems Co., Ltd.
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Royal Philips
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Qianjiang Kingphar Medical Material Co Ltd.
- 2025-10-21
CGMP/QSR/Medical Devices/Adulterated
LEVO AG
- 2025-10-07
CGMP/QSR/Medical Devices/Adulterated
Technological Medical Advancements LLC
- 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.
- 2025-08-26
CGMP/QSR/Medical Devices/Adulterated
Miach Orthopaedics
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)
- Medical Glove Guidance Manual: Guidance for Industry and FDA Staff (Status: Final)
- Postmarket Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Impact-Resistant Lenses: Questions and Answers: Guidance for Industry and FDA Staff (Status: Final)
- Medical X-Ray Imaging Devices Conformance with IEC Standards: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program: Guidance for Industry and Food and Drug Administration Staff (Status: Final)