(231 days)
A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Powdered Vinyl Examination Gloves
I am sorry, but based on the provided document, there is no information about the acceptance criteria or a study proving the device meets those criteria.
This document is a 510(k) clearance letter from the FDA for "Powdered Vinyl Examination Gloves" manufactured by Shijiazhuang Brethren Plastic Company, Limited. It indicates that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
The letter discusses regulatory aspects like general controls, GMP compliance, and labeling, and includes an "Indication For Use Statement." However, it does not contain:
- A table of acceptance criteria or reported device performance.
- Details about sample size, data provenance, or ground truth establishment for a test set.
- Information on expert involvement or adjudication methods.
- Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
- Information on a training set or how its ground truth was established.
The document's purpose is to grant market clearance based on substantial equivalence, not to detail the specific performance testing data that supported that equivalence.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 1 1999
Mr. Xin-Lai Zhou General Manager Shijiazhuang Brethren Plastic Company, Limited No. 37 Zhonghua South Street Shijiazhuang, Hebei CHINA
K983893 Re: Powdered Vinyl Examination Gloves Trade Name: Requlatory Class: I Product Code: LYZ Dated: May 20, 1999 May 24, 1999 Received:
Dear Mr. Xin-Lai Zhou:
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. A 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Xin-Lai Zhou
this response to your premarket notification Please note: r submission does not affect any obligation you might have under sections 531 through 542 of 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 (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 Other qeneral 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,
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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石家庄博森塑料制品有限公司 SHIJIAZHUANG BRETHREN PLASTIC CO., LTD. ND 205 ZHONGHUA SOUTH ST, SHIJIAZHUANG, HEBEI, CHINA FAX 86 -311-7024360 11-11-26-311-7021447
Attachment G
INDICATION FOR USE STATEMENT
510(K) Number(if known):
Device Name: Powdered Vinyl Examination Gloves
Indication For Use:
A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Truthfully Yours.
Xin-Lai Zhou
General Manager
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K983843 |
| Prescription Use | OR | Over-The-Counter Use X | |
|---|---|---|---|
| ------------------ | -- | ---- | ------------------------ |
(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.