FDA 510K Information

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Primer on FDA 510(k) Exemption

for Medical Gloves

All medical gloves are now exempt from FDA 510(k) Premarket Notification!

 As of, January 2021, the Department of Health and Human Services (HHS) made the FDA’s temporary exemption from the 510(k)-premarket notification process permanent for seven Class I medical devices. 

 On January 15, 2021, HHS published its “Notice about making permanent regulatory flexibilities during COVID-19 related to certain medical devices” (Federal Register Doc. #2021-00787).

 Through this Notice, HHS identified seven class I devices — all medical gloves — as permanently exempt from the 510(k) premarket notification requirements.

 

 V12 Health Gloves covered by this exemption:

 V12 Pista – Nitrile Medical Examination Glove:

Patient Examination Glove, Specialty; Product CodeLZA; Statute: 21 CFR 880.6250

 V12 Forza – Chemo Rated Medical Examination Glove:

Radiation Examination Glove, Specialty; Product CodeOPH; Statute: 21 CFR 880.6250

 Resources:

Legal Analysis by Frost Brown Todd, LLC - Attorneys at Law: FDA Permanently Exempts Seven Class I Gloves from 510(k) Premarket Notification Process

See also, https://www.lexology.com/library/detail.aspx?g=1c64d5b1-a91f-47b2-8176-27cc093a4e58

 HHS Notice Making Permanent Regulatory Flexibilities Provided During the COVID-19 Public Health Emergency by Exempting Certain Medical Devices From Premarket Notification Requirements.

 Federal Statute covering Medical glove exemptions from 510(k) registration: 21 CFR6250:

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES 

PART 880 -- GENERAL HOSPITAL AND PERSONAL USE DEVICES

Subpart G - General Hospital and Personal Use Miscellaneous Devices

SEC. 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 other than manufacturing. The final finished glove includes only residual powder from manufacturing.

(b) Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 54 FR 1604, Jan. 13, 1989; 66 FR 46952, Sept. 10, 2001; 81 FR 91730, Dec. 19, 2016; 84 FR 71815, Dec. 30, 2019]

   

 

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