POWDER FREE LATEX EXAMINATION GLOVES

K990901 · Apl Products Sdn. Bhd. · LYY · May 4, 1999 · General Hospital

Device Facts

• Record ID: K990901
• Device Name: POWDER FREE LATEX EXAMINATION GLOVES
• Applicant: Apl Products Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: May 4, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

This glove is a disposable device intended for medical purpose that is worn the examiner's hand to prevent contamination between patient and examiner.

Device Story

Powder-free latex examination glove; disposable; worn on examiner's hand. Acts as physical barrier to prevent cross-contamination between patient and examiner in medical settings. Manufactured by APL Products Sdn. Bhd. Contains 50 micrograms or less of total water extractable protein per gram.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Latex examination glove; powder-free; contains 50 micrograms or less of total water extractable protein per gram. Class I device, product code LYY.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand 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

MAY 4 1000

Mr. Son Hong Lee APL Products Sdn. Bhd. Lot 8961 & 8964, Batu 19, Jalan Bruas, 32400 Ayer Tawar, Perak Darul Ridzuan, MALAYSIA

K990901 Re : Powder-Free Latex Examination Gloves Trade Name: Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram Requlatory Class: I Product Code: LYY Dated: March 16, 1999 March 18, 1999 Received:

Dear Mr. Son Hong Lee:

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, qood 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. A 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 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.

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## Page 2 - Mr. Son Hong Lee

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 diaqnostic 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.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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## APL Products Sdn. Bhd.

(COMPANY NO.: 241845-A)

Lot 8961 & 8964, Batu19, Jalan Bruas, 32400 Ayer Tawar, Perak Darul Ridzuan, Malaysia. Tel No.: 605-6723152 Fax No.: 605-6726920 E-Mail : sonhong(@pc.jaring.my

Indications for Use Statement 3.0

## INDICATIONS FOR USE

APL Products Sdn. Bhd. Applicant

510(k) Number (if know)*

Contains 50 mily Device Name : POWDER FREE, LATEX EXAMINATION GLOVES - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - profession paragra

Indications For Use :

This glove is a disposable device intended for medical purpose that is worn the examiner's hand to prevent contamination between patient and examiner.

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

Prescription Use Per 21 CFR 801.109

Over-The-Counter OR (Optional Format 1-2-96)

For a new submission, do NOT fill in the 510(k) number blank. *

Clim S. Lim

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