LATEX EXAMINATION GLOVES POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL EXTRACTABLE PROTEIN)

• K Number: K991777
• Device Name: LATEX EXAMINATION GLOVES POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL EXTRACTABLE PROTEIN)
• Manufacturer: SELTOM PACIFIC SDN. BHD.
• Date Cleared: 1999-08-31 ( 98 days)
• Product Code: LYY , JUL
• Regulation Number: 880.6250
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient. It is a single use disposable glove.

Device Description

LATEX Powder Free Patient Examination Gloves with A PROTEIN LABELING CLAIM 2 50 MICROGRAMS OF TOTAL EXTRACTABLE PROTETH

AI/ML Overview

The provided text is a letter from the FDA regarding the clearance of a medical device, specifically "Latex Examination Gloves Powder-Free with Trade Name: Protein Labeling Claim (50 Micrograms or Less Total Extractable Protein)".

This document is a regulatory approval letter and does not contain the information requested regarding:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The letter simply states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices. It lists the product code and the indications for use.

To answer your questions, one would need to refer to the actual 510(k) submission (K991777) or related testing documentation, which is not present in the provided text.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle, with three curved lines representing its wings and tail feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 31 1999

Mr. S. Segaran Managing Director Seltom Pacific Sdn. Bhd. Lot 25, Jalan PJS 7/17 Sunway Industrial Park 46150 Petaling Jaya, Selangor, MALAYSIA

K991777 Re : Latex Examination Gloves Powder-Free with Trade Name: Protein Labeling Claim (50 Micrograms or Less Total Extractable Protein) Requlatory Class: I LYY Product Code: July 8, 1999 Dated: Received: July 12, 1999

Dear Mr. Segaran

ーイ

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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register.

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Page 2 - Mr. Segaran

premarket notification submission does not affect any premation you might have under sections 531 through 542 of obligation 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 described in your 510\n, promience of your device to a legally marketed predicate device results in a classification for your marice and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (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" (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 [phone] or [phone] or at its internet address "http://www.fdfa.gov/cdrh/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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SELTOM PACIFIC SDN. BHD.

SELTOM PACIFIC

(CO. NO. 256686-M) Lot 25, Jalan PJS 7/17, Sunway Industrial Park, 46150 Petaling Jaya, Selangor, Malaysia.

603-7356010 -5826010 603-7342713 -Mail: [e-mail]

INDICATIONS FOR USE

Applicant

SELTOM PACIFIC SDN BHD

510(k) Number

K9911777

Device Name

LATEX Powder Free Patient Examination Gloves with A PROTEIN LABELING CLAIM 2 50 MICROGRAMS OF TOTAL EXTRACTABLE PROTETH Indications for Use:-

A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

It is a single use disposable glove.

Stawberchi

sion Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 8991777 510(k) Number .

Regulation Number and Section

§ 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.