(43 days)
This glove is a disposable device intended for medical purpose that is worn the examiner's hand to prevent contamination between patient and examiner.
NITRILE PATIENT EXAMINATION GLOVES, POWDER FREE
The provided text is a 510(k) Pre-market Notification communication from the FDA to Asia Pacific Latex Berhad regarding Nitrile Patient Examination Gloves, Powder-Free. It is not a study or report on the performance of an AI/ML medical device. Therefore, I cannot provide the requested information as the document does not contain any details about acceptance criteria, device performance, study design, expert involvement, or ground truth for an AI/ML device.
The document is a regulatory approval letter for a physical medical device (gloves), confirming it is substantially equivalent to existing devices.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The eagle is a common symbol of the United States, representing freedom and strength.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 1 1998
Mr. Lee Soon Hong Managing Director Asia Pacific Latex Berhad No. 14, Jalan Taiping, 33000 Kuala Kangsar, Perak, Darul Ridzuan, MALAYSIA
Re : K982274 Trade Name: Nitrile Patient Examination Glove Powder-Free Requlatory Class: I Product Code: LZA Dated: June 26, 1998 Received: June 29, 1998
Dear Mr. Lee Soon Honq:
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 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. ਜ 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 regulation 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. Lee Soon Hong
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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
S. Duitman for
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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ASIA PACIFIC LATEX BERHAD (COMPANY NO .: 49137-X)
No. 14, Jalan Taiping, 33000 Kuala Kangsar, Perak Darul Ridzuan, Malaysia. Fax No .: 605-7768101 E-Mail : sonhong@gc.jaring.my Tel No.: 605-7765103, 605-7768250
Indications for Use Statement 3.0
INDICATIONS FOR USE
ASIA PACIFIC LEATEX BERHAD Applicant
98 2274 510(k) Number (if know)*
Device Name : NITRILE PATIENT EXAMINATION GLOVES, POWDER FREE
Indications For Use
This glove is a disposable device intended for medical purpose that is worn the examiner's hand to prevent contamination between patient and examiner.
PLESE DO NOT WEITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use Per 21 CFR 801.109
Over-The-Counter (Optional Format 1-2-96)
3
- For a new submission, do NOT-fill in the 510(k) number blank.
Clun S. Lohn
OR
Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
§ 880.6250 Non-powdered patient examination glove.
(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.