TA CHIA POWDERED NON-STERILE NITRILE PATIENT EXAMINATION GLOVES

K990575 · Ta Chia Rubber Ind. Corp. · LZA · May 4, 1999 · General Hospital

Device Facts

• Record ID: K990575
• Device Name: TA CHIA POWDERED NON-STERILE NITRILE PATIENT EXAMINATION GLOVES
• Applicant: Ta Chia Rubber Ind. Corp.
• Product Code: LZA · General Hospital
• Decision Date: May 4, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Device is a powdered, non-sterile nitrile patient examination glove. Used by healthcare professionals in clinical settings to provide a protective barrier between the examiner and the patient, preventing cross-contamination. The glove is worn on the hand or finger during medical examinations. It is a disposable, single-use device.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Nitrile rubber. Form factor: Disposable, powdered, non-sterile examination glove. Energy source: None. Connectivity: None.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger 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

4 1999 MAY

Ms. Chin-Ming Yang President TA CHIA RUBBER IND. CORP. LTD. 903, Chung Shan Road Sec. 2, TA Chia, Taichung TAIWAN, R.O.C.

K990575 Re : TA CHIA Powdered Non-Sterile Nitrile Trade Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA । ਭੇਰੇ ਰ February 13, Dated: February 23, 1999 Received:

## Dear Ms. Chin-Ming Yang

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the marice 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, rood, brag, and of 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 be babyour of bacting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ 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 vertif boommay 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 premation you might have under sections 531 through 542 of

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Page 2 - Ms. Chin-Ming Yang

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,

Timothy A. Ulatowski

Direct 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

K990575

510(K) Number (if known): Applied for Device Name: Powdered Non-Sterile Nitrile Examination Gloves

Indications For Use:

A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Ta Chia Rubber Ind. Corp., Ltd.

Chim CHIN MING YANG /President.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Clim S. Lim

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

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)