SOUTHLAND POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM

K990746 · Southland Products Co., Ltd. · LYY · Mar 23, 1999 · General Hospital

Device Facts

• Record ID: K990746
• Device Name: SOUTHLAND POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM
• Applicant: Southland Products Co., Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Mar 23, 1999
• 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 purpose that is worn on the examiner hands or fingers to prevent contamination between patient and examiner.

Device Story

Disposable latex examination glove; worn by healthcare providers on hands or fingers; serves as barrier to prevent cross-contamination between patient and examiner; features protein labeling claim of 50 micrograms or less of total water extractable protein per gram; intended for general medical use.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Latex material; powder-free; protein content limited to 50 micrograms or less per gram; disposable form factor.

Indications for Use

Indicated for use as a disposable medical glove worn on examiner hands or fingers 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

MAR 2 3 1994

Mr. Nq Peng Leong Director Southland Products Company, Limited 55 Rajyindee Road Hatyai Songkhla 90110 THAILAND

K990746 Re : Southland Powder-Free Latex Examination Trade Name: Gloves with Protein Labeling Claim (50 micrograms or less) Regulatory Class: I Product Code: LYY Dated: March 1, 1999 Received: March 8, 1999

Dear Mr. Ng Peng Leong

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, Druq, 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਖੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 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

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Page 2 - Mr. Ng Peng Leong

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 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,

Susan Runnoe

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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## INDICATION FOR USE STATEMENT

Applicant

510K Number (if known)

Device Name

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2018-04-04 10:48:10 来源:

: SOUTHLAND PRODUCTS CO., LTD

: K990746

: Powderfree patient latex examination gloves, with protein label claim ( 50 micrograms or less of total water extractable protein per gram.)

Indications for use

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner hands or fingers 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 )

Chiu S. Lin

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

Prescription Use OR Over-The-Counter Per 21 CFR 801.109