HEALTH-PLUS SANITEX,RELIANCE PRE-POWDERED MULTI-PLY LATEX EXAMINATION GLOVE (NATURAL RUBBER LATEX-NITRILE-CONSTRUCTION W

K992523 · Pamitex Industries Sdn Bhd · LYY · Oct 18, 1999 · General Hospital

Device Facts

• Record ID: K992523
• Device Name: HEALTH-PLUS SANITEX,RELIANCE PRE-POWDERED MULTI-PLY LATEX EXAMINATION GLOVE (NATURAL RUBBER LATEX-NITRILE-CONSTRUCTION W
• Applicant: Pamitex Industries Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Oct 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

A 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.

Device Story

Pre-powdered multi-ply latex patient examination glove; natural rubber latex and nitrile construction. Designed for use by healthcare professionals or in general medical settings to provide a barrier against contamination. Device is disposable and intended for single use. Protein content labeled at 68.25 micrograms or less per gram of glove. Operates as a physical barrier; no electronic or software components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Multi-ply construction using natural rubber latex and nitrile. Pre-powdered. Protein content claim: 68.25 micrograms or less per gram of glove. Class I medical device.

Indications for Use

Indicated for use as a disposable medical glove worn by examiners to prevent cross-contamination between patient and examiner.

Regulatory Classification

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

OCT 1 8 1999

Mr. Said Awang Product Development & Technical QA Pamitex Industries Sdn. Bhd. Batu 2½ Jalan Rasah 70300 Seremban Negeri Sembilan Darul Khusus, Malaysia

Re : K992523

> Health-Plus Sanitex, Reliance Pre-Powdered Trade Name: Multi-Ply Latex Examination Glove (Natural Rubber Latex-Nitrile-Construction with Protein Content Label Claim (68.25 micrograms or less per glove) Requlatory Class: I Product Code: LYY July 14, 1999 Dated: Received: July 28, 1999

Dear Mr. Awang:

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 aqainst 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. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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

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Page 2 - Mr. Awang

the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation 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.fda.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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510(k) Number (if known): ------ K 99.2 ≤ ≤ 2 3 ------------------------------------------------------------------------------------

DEVICE NAME : Pre-Powdered Multi-ply Latex Patient Examination Glove (Natural Rubber Latex-Nitrile-Construction) with Protein Content labeling claim 68.25 micrograms or less per gram of gloves.

INDICATIONS FOR USE:

A 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.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use --------------------(Per 21 CFR 801.109)

OR Over The Counter Use---------\X

(Optional Format 1-2-95)

Oliver S. Làn

(Division Sign-Off) Division of Dental, Infection Cor and General Hospital 1 1 (k) Number _