(84 days)
A 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 examiners.
Multi-ply Powder-free Latex Examination Gloves with Protein content labeling claim(50ug/g or less total water extratable protein content)
This is a 510(k) premarket notification letter from the FDA regarding "Multi-Ply Powder-Free Latex Examination Gloves With Protein Content Labeling Claim (50ug/g Or Less Total Water Extractable)". It is a regulatory approval document and does not contain the information requested about acceptance criteria, device performance, study details, or ground truth establishment.
The letter explicitly states: "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..." This indicates a "substantial equivalence" determination, not a study demonstrating performance against specific acceptance criteria in the way a clinical or AI performance study would.
Therefore, I cannot provide the requested information based on the provided text.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 0 2000
Mr. Said Awang Product Development and Technical QA Pamitex Industries Sdn. Bhd. Batu 2½ Jalan Rasah 70300 Seremban Negeri Sembilan Darul Khusus, Malaysia
K993918 Re: Multi-Ply Powder-Free Latex Examination Trade Name: Gloves With Protein Content Labeling Claim (50ug/g Or Less Total Water Extractable) Regulatory Class: I Product Code: LYY Dated: December 14, 1999 December 17, 1999 Received:
Dear Mr. Awang:
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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੇ 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
{1}------------------------------------------------
Page 2 - Mr. Awang
the Federal Register. Please note: this response to your premarket notification submission does not affect any premarker nocarrohave under sections 531 through 542 of obligation you may the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as Info iceed warr 510 k) premarket notification. The FDA described in your sia equivalence of your device to a legally rinding of bubbeandarice results in a classification for your markets predicate awits 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 information on your responsibilities under the Act may be Information on your respon 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
Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
K993918 SIO(K) MUMBER (IF KNOWN):
Multi-ply Powder-free Latex Examination Gloves with Protein DEVICE NAME : content labeling claim(50ug/g or less total water extratable INDICATIONS FOR USE: protein content)
A 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 examiners.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use \$\frac{X}{(Optional Format 1-2-96)}
Qisin S. Lim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospita 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.