(47 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.
POWDER FREE, LATEX EXAMINATION GLOVES - Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for "Powder-Free Latex Examination Gloves" and an "Indications for Use Statement".
It confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. It does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes, data provenance, or the nature of a test set.
- Information on experts, ground truth establishment, or adjudication methods.
- Data on multi-reader multi-case studies or standalone algorithm performance.
- Information about training sets or how their ground truth was established.
The document is purely an FDA clearance confirmation and related administrative information.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 4 1000
Mr. Son Hong Lee APL Products Sdn. Bhd. Lot 8961 & 8964, Batu 19, Jalan Bruas, 32400 Ayer Tawar, Perak Darul Ridzuan, MALAYSIA
K990901 Re : Powder-Free Latex Examination Gloves Trade Name: Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram Requlatory Class: I Product Code: LYY Dated: March 16, 1999 March 18, 1999 Received:
Dear Mr. Son Hong Lee:
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, qood 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. Please note: this response to your premarket notification 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.
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Page 2 - Mr. Son Hong Lee
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 diaqnostic 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
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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APL Products Sdn. Bhd.
(COMPANY NO.: 241845-A)
Lot 8961 & 8964, Batu19, Jalan Bruas, 32400 Ayer Tawar, Perak Darul Ridzuan, Malaysia. Tel No.: 605-6723152 Fax No.: 605-6726920 E-Mail : sonhong(@pc.jaring.my
Indications for Use Statement 3.0
INDICATIONS FOR USE
APL Products Sdn. Bhd. Applicant
510(k) Number (if know)*
Contains 50 mily Device Name : POWDER FREE, LATEX EXAMINATION GLOVES - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - profession paragra
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 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
Over-The-Counter OR (Optional Format 1-2-96)
For a new submission, do NOT fill in the 510(k) number blank. *
Clim S. Lim
(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.