SOUTHLAND POWDERFREE (POLYMER-COATED) LATEX EXAMINATION GLOVES

K990751 · Southland Products Co., Ltd. · LYY · Mar 23, 1999 · General Hospital

Device Facts

• Record ID: K990751
• Device Name: SOUTHLAND POWDERFREE (POLYMER-COATED) LATEX EXAMINATION GLOVES
• 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

Southland Powder-Free (Polymer-Coated) Latex Examination Gloves are disposable, single-use devices. Worn by healthcare examiners on hands or fingers during patient examinations. Primary function is to serve as a protective barrier to prevent cross-contamination between patient and examiner. Used in clinical or medical settings. No complex processing, software, or electronic components involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Latex material with polymer coating. Disposable, non-sterile examination glove. Form factor: hand-shaped flexible barrier. No electronic, software, or energy-based components.

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. 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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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 1999

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

K990751 Re : Southland Powder-Free (Polymer-Coated) Latex Trade Name: Examination Gloves Regulatory Class: I Product Code: LYY March 1, 1999 Dated: March 8, 1999 Received:

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, 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 regulation (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,

Susan Currie

Timothy A. Ulatowski ಗಿ 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

: SOUTHLAND PRODUCTS CO., LTD

510K Number (if known)

: K990751

Device Name

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374 17 17

:

: Powderfree( Polymer coated ) patient latex examination gloves,

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 )

Olu S. Lin

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

**Prescription Use** ***_*** OR **Over-The-Counter** X
Per 21 CFR 801.109 **_**