INNOVATIVE GLOVES LATEX EXAMINATION GLOVES POWDERFREE WITH PROTEIN LABELING CLAIM [50 MICROGRAMS OR LESS]

K993567 · Innovative Gloves Co;, Ltd. · LYY · Jan 12, 2000 · General Hospital

Device Facts

• Record ID: K993567
• Device Name: INNOVATIVE GLOVES LATEX EXAMINATION GLOVES POWDERFREE WITH PROTEIN LABELING CLAIM [50 MICROGRAMS OR LESS]
• Applicant: Innovative Gloves Co;, Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Jan 12, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A Medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and patient.

Device Story

Latex examination glove; powder-free; features protein content labeling claim of 50 micrograms or less. Used by healthcare and similar personnel in clinical or point-of-care settings to provide a protective barrier on the hands. Prevents contamination between personnel and patients during examinations or procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Latex examination glove; powder-free; protein content labeled at 50 micrograms or less. Class I medical device.

Indications for Use

Indicated for use by health care and similar personnel as a protective barrier to prevent cross-contamination between the wearer and the patient.

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

JAN 1 2 2000

Mr. Rajeev Kumar Sood President & CEO Innovative Gloves Company, Ltd. 11 Chotevittayakul 3 Road Khohong, Hatyai, Songkhla 90110 Thailand

K993567 Re :

Innovative Gloves Latex Examination Gloves Trade Name: Powderfree With Protein Labeling Claim [50 Micrograms or Less | Regulatory Class: I Product Code: LYY November 30, 1999 Dated: Received: December 7, 1999

Dear Mr. Sood:

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 requlations 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) 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in

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Page 2 - Mr. Sood

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 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.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

imothy A. Ulatowski Dinector Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## บริษัท อินโนเวทีนใ โทลฟล์ จากัต INNOVATIVE GLOVES CO.,LTD. 11 ถ.โชติวิทยะกุล 3 ต.หาดใหญ่ อ.หาดใหญ่ จ.สงขลา 90110 11 Chotevittayakul 3 Rd., Hatyai, Songkhia 90110 Tel. [phone] Fax: [phone] Mobile: [phone] E-mail: [e-mail]

Subject.k 993567

Ammendment No: 1

Page 1 of 1

## INDICATIONS FOR USE

## Applicants Name: INNOVATIVE GLOVES CO; LTD

510(k) Number(if known): k 993567

Device Name Latex Examination Powder Free with proteins content label claim 50 MICROGRAMS OR LESS

## INDICATIONS FOR USE:

"A Medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and patient."

Concurrence of CDRH,Office of Device Evaluation(ODE)

Prescription Use -----(Per21CFR801.109) Or Over- The- Counter- Use (Optional Format 1-2-96)

Aufen Las and

Qian S. Lin

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