POWDER FREE LATEX EXAMINATION GLOVES

K033533 · Apl International Incorporated Limited · LYY · Jun 24, 2004 · General Hospital

Device Facts

• Record ID: K033533
• Device Name: POWDER FREE LATEX EXAMINATION GLOVES
• Applicant: Apl International Incorporated Limited
• Product Code: LYY · General Hospital
• Decision Date: Jun 24, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.

Device Story

Powder-free latex examination gloves; disposable; worn on hands/fingers by healthcare personnel during patient examinations. Function: physical barrier to prevent cross-contamination between patient and examiner. Contains 50 micrograms or less of total water-extractable protein per gram. Used in clinical settings; no specialized operation required.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Latex. Form factor: Powder-free examination glove. Protein content: ≤ 50 micrograms/gram water-extractable protein. Class I device.

Indications for Use

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

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

JUN 2 4 2004

Mr. Lee Son Hong (Chief Executive Officer) APL International, Incorporated Limited Go Dau Industrial Zone Long Thanh District Dong Nai Province VIETNAM

Re: K033533

Trade/Device Name: Powder Free Latex Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: January 27, 2004 Received: May 20, 2004

Dear Mr. Hong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 merslate commerce prives that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents of an 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Mr), it may of buryou in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or routish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Hong

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that PDA 3 issualled on a basecures complies with other requirements mean that ITDA has made a determinations administered by other Federal agencies. of the Act of ally receial statutes and regarants, including, but not limited to: registration You must comply with an the Fee 3 requirements (art 801); good manufacturing practice and listing (21 CFR Pat 807), laooiing (21 CFR Party), 1
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maiioning your substantial equivalence of your device to a premarket notification. The PDF milling or seessification for your device 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), If you desire specific advice for your de roll of the see-en the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general meetirs. International and Consumer Assistance at its toll-free Drimber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## APL International Incorporated Limited.

Go Dau Industrial Zone Long Thanh District Dong Nai Province Vietnam

Tel./Fax. : [phone]

## Indications for Use Statement

510(K) Number (if known) : K 033533

:

Device Name

Powder Free Latex Examination Gloves Contains 50 microgram or less of total water Extractable Protein per gram

## Indications For Use

A Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.

| Prescription Use | |
|----------------------------|--|
| (Part 21CFR 801 Subpart D) | |

AND/OR

| Over-The-Counter Use | <div> <span style="font-size:2em;">✔</span> </div> |
|------------------------|----------------------------------------------------|
| (21 CFR 807 Subpart C) | |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Reim Muly

(Division Sign-on }
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

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510(k) Number: K033533