← Product Code [LYY](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY) · K971514

# REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE (K971514)

_London International Group, Inc. · LYY · Oct 29, 1997 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K971514

## Device Facts

- **Applicant:** London International Group, Inc.
- **Product Code:** [LYY](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY.md)
- **Decision Date:** Oct 29, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6250
- **Device Class:** Class 1
- **Review Panel:** General Hospital

## Indications for Use

An 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.

## Device Story

Regent Biogel Diagnostic Powder-Free Examination Glove is a disposable, non-sterile glove designed for medical examinations. It functions as a physical barrier worn on the examiner's hand or finger to prevent cross-contamination between the patient and the examiner. The device features a specific labeling claim of 50 micrograms or less of protein content. It is intended for use in clinical or medical settings by healthcare professionals or other users requiring barrier protection.

## Clinical Evidence

No clinical data provided. Substantial equivalence is based on the device's intended use as a barrier protection glove and compliance with general controls for Class I medical devices.

## Technological Characteristics

Disposable, non-sterile examination glove. Features powder-free construction. Labeled for protein content of 50 micrograms or less. Class I medical device.

## Regulatory 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.

## Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Neil Anderson London International Group Incorporated 2926 Columbia Highway Dotham, Alabama 36303

OCT 2 9 1997

Re : K971514 Regent Biogel Diagnostic Powder-Free Trade Name: Examination Glove with Protein Content Labeling Claim of 50 Micrograms or less Requlatory Class: I Product Code : _ LYY _______ . October 21, 1997 Dated: Received: October 22, 1997

Dear Mr. Anderson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any ebligation you might have under sections 531 -

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Page 2 - Mr. Anderson

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

U. Victurus

Timothy A. II atows Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## APPENDIX II

## Indications for Use

Applicant - London International Group (Regent Medical)

510(K) Number (if known) K971514

Device Name - Non-sterile examination glove)

Indications for use:

50 MICROGRAMS OR LESS "An examination glove is a disposable device intended for medical purposes

Regent Biogel Diagnostic Procedure With Protein Content Labeling Claim C

WDER-HR

that is worn on the examiner's hand or finger to prevent contamination between patient and examiner."

Concurrence of CDRH Office of Device Evaluation

Clins S. him

Prescription Use

OR Over the Counter X

Per 21 CFR 801.109

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K971514](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K971514)

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