BIOPRO, NITRILON, CORRECT TOUCH- NITRILE POWDERED EXAMINATION GLOVES (GREEN/ PURPLE)

K994276 · Biopro (M) Sdn Bhd · LZA · Oct 20, 2000 · General Hospital

Device Facts

• Record ID: K994276
• Device Name: BIOPRO, NITRILON, CORRECT TOUCH- NITRILE POWDERED EXAMINATION GLOVES (GREEN/ PURPLE)
• Applicant: Biopro (M) Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Oct 20, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

BioproTM, NitrilonTM, Correct Touch® (Powdered) is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to present contamination between patient and examiner.

Device Story

Disposable nitrile examination gloves; worn on hands of healthcare or similar personnel; intended to provide barrier protection to prevent cross-contamination between patient and examiner. Device is non-sterile, powdered, and available in green or purple. Used in clinical or similar settings. No complex electronics, software, or algorithms involved.

Clinical Evidence

Bench testing only.

Technological Characteristics

Nitrile rubber material; powdered; disposable; examination glove form factor; non-sterile.

Indications for Use

Indicated for use by healthcare and similar personnel as a disposable patient examination glove to prevent 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 '

OCT 2 0 2000

Mr. James H. Lale Chief Executive Officer Biopro (M) SDN BHD Lot 14, PT. 4204 Lingkarn Sultan Hishamuddin, North Port Industrial Estate Port Klanq MALAYSIA

K994276 Re : Biopro, Nitrilon, Correct Touch - nitrile Trade Name: Powdered Examination Gloves Requlatory Class: I Product Code: LZA October 4, 2000 Dated: October 6, 2000 Received:

Dear Mr. Lale:

We have reviewed your Section 510(k) notification of intent to we have reviewed referenced above and we have determined the market the substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 20, 1976, devices mainsofate of the Medical Device Amendments, or to che chat 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 Regulations, Title 21, Parts 800 to 895. ਰ 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:

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Page 2 - Mr. Lale

this response to your premarket notification submission does chis response to your pro you might have under sections 531 not afrect any obrigation for devices under the Electronic chrough 342 or the not 10- 10- 10- 10- 10- 10-1 10-1 10-1 regulations.

This letter will allow you to begin marketing your device as Inis lecter will arem for market notification. The FDA described in your sisting puivalence of your device to a legally marketed predicate device results in a classification for your marketed predicate actts 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 compreason and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note "Misbranding by reference to the regulation entitled, 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,

atural

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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510(k) Submission - Nitrile Powdered Examination Gloves(Green, Purple) Submitted by Biopro (M) Sdn Bhd Tel [phone] Fax [phone]

Indications for Use Statement: 3.0

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510(k) Number (if known) :

Device Name:

Applicant:

Biopro™, Nitrilon™, Correct Touch® or any other private labeling Nitrile Powdered Examination Gloves (Green, Purple)

Indications For Use:

BioproTM, Nitrilon™, Correct Touch® (Powdered) is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to present contamination between patient and examiner.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Devices Evaluation (OBE)

Olin S. lin

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

Prescription Use (Per 21 CFR 801.109)

OR

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