(154 days)
A patient examination glove is a disposable device intended for medical purposes that is wom on the examiner's hard and finger to prevent Contamination between patient and examiner.
Powdered Latex Examination Gloves With Trade Name: Protein Content Labeling Claim
I am sorry, but the provided text does not contain the information required to answer your request about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for "Powdered Latex Examination Gloves With Trade Name: Protein Content Labeling Claim," dated June 24, 1997.
This letter primarily states that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to the market. It discusses regulatory classifications, general controls, and responsibilities under the Federal Food, Drug, and Cosmetic Act.
There is no mention of:
- Specific acceptance criteria for device performance.
- Details of any study conducted to prove the device meets performance criteria (such as sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth types/establishment).
- Reported device performance metrics.
Therefore, I cannot generate the table or provide the requested study details based on the given text.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three lines forming its body and wings, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Lim Kuang Sia 'Kossan Latex Industries (M) Snd. Bhd. Lot 16632, 5 1/4 Mile, Jalan Meru, 40150 Klang, JUN 2 4 1997 Selangor MALAYSIA
K970222 Re : Powdered Latex Examination Gloves With Trade Name: Protein Content Labeling Claim Requlatory Class: I Product Code: LYY Dated: May 20, 1997 Received: May 22, 1997
Dear Mr. Sia:
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, Druq, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੈ 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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 miqht have under sections 531 through 542 of
{1}------------------------------------------------
Page 2 - Mr. Sia
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) 594-4618. 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) 63β-2041 or at (301) 443-6597.
Sincerely yours,
Timothy A. Ulatowski
Time Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
:: 422014 1. 1. 3 8 8 8 3 2 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8
Page 17 ol
中古屋下 をつきているときてきるというとき
ﺎﺭ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
5 1 O(k) Number (il known): 1970222
Device Name: "Hate Bannation Glove with Protein Content Labeling Claim
Indications for Use:
A patient examination glove is a disposable device intended for medical purposes that is wom on the examiner's hard and finger to prevent Contamination between patient and examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
一般都有一一一次出張書書榜演演 三一三八歲在第二十八
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| k) Number | K070222 |
| Prescription Use (Per 21 CFR 801.109) | 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.