UNISEAL GLOVES LOW PROTEIN POWDERED

K981979 · American Healthcare Products (M) Sdn Bhd · LYY · Nov 30, 1998 · General Hospital

Device Facts

• Record ID: K981979
• Device Name: UNISEAL GLOVES LOW PROTEIN POWDERED
• Applicant: American Healthcare Products (M) Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Nov 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

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

Device Story

Disposable latex examination glove; worn by healthcare examiners to provide barrier protection; prevents cross-contamination between patient and examiner; intended for medical use; powdered; features protein content labeling claim of 100 micrograms or less.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Latex examination glove; powdered; protein content labeled at 100 micrograms or less; Class I device.

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

NOV 30 1998

Ms. Tarani Devi Exe. Director American HealthCare Products (M) Sdn. Bhd. PT 7521, Taman Semarak II, Light Industrial Park 71800 Nilai, Negeri Sembilan, MALAYSIA

Re : K981979 Trade Name: Uniseal Latex Examination Gloves, Powdered with Protein Content Labeling Claim (100 Micrograms or Less) Regulatory Class: I Product Code: LYY August 13, 1998 Dated: October 19, 1998 Received:

Dear Ms. Devi:

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 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 Requlations, Title 21, Parts 800 to 895. ਰਿ 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 Register. 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 - Ms. Devi

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 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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## INDICATIONS FOR USE STATEMENT

| 510(K) Number | K981979 |
|---------------|------------------------------------------------------------------------------|
| Device Name | Uniseal Powdered Latex Examination Glove with Protein Content Labeling Claim |
| | (100 micrograms or less) |

Indication for us :

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

(PLEASE 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) OR

Over - The-Counter Use
(Optical Format 1-2-96)

Olin S. Lin

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

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