(305 days)
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.
Biopro™, Nitrilon™, Correct Touch® or any other private labeling Nitrile Powdered Examination Gloves (Green, Purple)
This looks like a 510(k) clearance letter for examination gloves. The provided text does not contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device.
The document is a regulatory clearance for a medical device (nitrile examination gloves) and confirms its substantial equivalence to legally marketed predicate devices. It discusses general controls, manufacturing practices, and labeling, but not the kind of performance evaluation typically associated with AI/ML systems.
Therefore, I cannot extract the requested information regarding acceptance criteria and studies that prove device performance for an AI/ML device from this text. The questions you've posed are pertinent to evaluating AI/ML medical devices, but the provided text describes a much simpler, non-AI medical device.
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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 (301) 594-4692. Additionally, for questions on compreason and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 (603) 376-1390 Fax (603) 376-1787
Indications for Use Statement: 3.0
| Biopro (M) Sdn Bhd | |
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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)
§ 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.