OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE

• K Number: K984064
• Device Name: OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE
• Manufacturer: OMNI INTL., INC.
• Date Cleared: 1999-01-08 ( 53 days)
• Product Code: KGO
• Regulation Number: 878.4460
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

A glove to be worn by operating room personnel to protect a surgical wound from contamination.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device: "OmniGrip Latex Surgeons Gloves, Powder Free". This document is an FDA letter confirming substantial equivalence to a predicate device, which means no new clinical studies were likely performed to prove the device's efficacy or safety.

Therefore, the following information cannot be extracted from this document:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
8. The sample size for the training set
9. How the ground truth for the training set was established

This document primarily states that the OmniGrip Latex Surgeons Gloves, Powder Free, are "substantially equivalent" to legally marketed predicate devices. This determination is based on the device's indications for use and compliance with general controls regulations (such as annual registration, device listing, good manufacturing practices, and labeling), rather than new performance studies with specific acceptance criteria and detailed study data.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the eagle. The text is in all caps and is oriented to follow the curve of the circle.

8 1999 JAN

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. William E. Patton Vice President Regulatory Affairs OmniGrace (Thailand) Ltd. 641 Moo 5 Kanchanawanit Road Tambon Banpru Hatyai, Songkhla, 90250 THAILAND

Re : K984064 OmniGrip, Latex Surgical Glove, Powder-Free Trade Name: Requlatory Class: I Product Code: KGO Dated: November 12, 1998 Received: November 16, 1998

Dear Mr. Patton:

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 legally marketed predicate 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 of the Act. The general controls provisions of the Act include requirements for annual reqistration, 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Patton

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 findinq 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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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OmniGrace (Thailand) LTD 510(k) Premarket Notification Surgeon Glove, Latex, Powder Free

November 12, 1998 Attachment II

INDICATIONS FOR USE

Applicant : OmniGrace (Thailand) Ltd.

Device Name:	OmniGrip Latex Surgeons Gloves, Powder Free
510(k) Number (if known):	K984064

Indications For Use :

A glove to be worn by operating room personnel to protect a surgical wound from contamination.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Office Of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices

510(k) Number	Y984066
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Prescription Use
OR Over The Counter	X

6

Per 21 CFR 801.109

Regulation Number and Section

§ 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 includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).