(244 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 examiner. The extra thickness of this glove is suitable for use in an environment of higher risks, such as Paramedics, Emergency Room, etc. This glove may also provide additional protection in other areas where users are handling certain hazardous chemicals such as chemotherapy drugs, as penetration and permeation to these chemicals are prevented.
Absogel Powder Free Latex Examination Gloves with Protein Content (50 micrograms or less) and Chemotherapy Drug Protection Claims
This document is a 510(k) clearance letter from the FDA for a medical device: "Absogel Powder Free Latex Examination Gloves with Tested For Use With Chemotherapy Drugs & Protein Content (50 micrograms or less) Labeling Claims".
The document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way you've described, which typically applies to AI/software as a medical device (SaMD) or diagnostic devices. Instead, this is a clearance for a physical medical glove.
Here's why the requested information cannot be extracted from this document:
- No AI/Software: This document is for latex examination gloves, a physical product, not an AI or software device. Therefore, concepts like "algorithm only performance," "human-in-the-loop performance," "effect size of human readers improving with AI," "training set," "test set," "ground truth," and "expert adjudication" are not applicable.
- Substantial Equivalence: The FDA clearance is based on "substantial equivalence" to a predicate device, meaning the new device is as safe and effective as a legally marketed device. This process generally involves demonstrating that the new device has the same intended use, technological characteristics, and performs similarly to the predicate. It does not typically involve the kind of rigorous performance studies with acceptance criteria and ground truth methodologies you've asked about for AI/SaMD.
- Product Performance Data (for gloves): While gloves do have performance criteria (e.g., barrier integrity, tensile strength, protein content, chemotherapy drug permeation), these are verified through established testing standards (e.g., ASTM standards) rather than the type of clinical or reader studies you've described. The document mentions "Tested For Use With Chemotherapy Drugs & Protein Content (50 micrograms or less) Labeling Claims," which implies such testing was done and submitted as part of the 510(k) application, but the details of those tests (acceptance criteria, methodologies, results) are not in this letter.
Therefore, I cannot provide the requested table and study details as they are not present in the provided FDA clearance letter for this type of medical device.
The document primarily states:
- Device Name: Absogel Powder Free Latex Examination Gloves with Protein Content (50 micrograms or less) and Chemotherapy Drug Protection Claims
- Regulatory Class: I
- Product Code: LYY
- Indicated Use: Disposable device intended for medical purposes, worn on hand/finger to prevent contamination. Extra thickness for higher risks (Paramedics, ER). Additional protection when handling certain hazardous chemicals like chemotherapy drugs (penetration/permeation prevented).
To get the type of information you are asking for, you would need to look at the actual 510(k) submission on file (K990677) where the manufacturer would have submitted their test data for things like chemotherapy drug permeation and protein content, demonstrating compliance with relevant standards. However, even those wouldn't align with the "AI/SaMD" specific questions you've posed.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle contains a stylized image of a bird or other winged creature. The image is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 1 1999
Ms. Phnq Li Kim Director of Operation and Administration AMPri Rubberware Industries Sdn. Bhd. Lot Nos. B5 & B6, Kawasan Perindustrian MIEL Batang Kali Phase II, 44300 Batang Kali, Selangor, MALAYSIA
Re : K990677 Trade Name: Absogel Powder Free Latex Examination Gloves with Tested For Use With Chemotherapy Drugs & Protein Content (50 micrograms or less) Labeling Claims Regulatory Class: I Product Code: LYY August 18, 1999 Dated: Received: Auqust 20, 1999
Dear Ms. Phnq Li Kim:
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 enclosurc) 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 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. ರಿ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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
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Page 2 - Ms. Phnq Li Kim
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 requlations.
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 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
y A. Ulatowsk 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) Number (if known); K990677
Device Name: Absogel Powder Free Latex Examination Gloves with Protein Content (50 micrograms or less) and Chemotherapy Drug Protection Claims
Indications For Use:
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 examiner. The extra thickness of this glove is suitable for use in an environment of higher risks, such as Paramedics, Emergency Room, etc.
This glove may also provide additional protection in other areas where users are handling certain hazardous chemicals such as chemotherapy drugs, as penetration and permeation to these chemicals are prevented.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONȚINUE 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
Image /page/2/Picture/13 description: The image contains a handwritten letter 'X' next to the letter 'e'. The 'X' is larger than the 'e' and is positioned to the right of it. The 'X' is formed by two intersecting diagonal lines, and the 'e' is a lowercase letter with a curved shape.
(Optional Format 1-2-96)
Thien S. Lin
(Division Sign-Off Division of Dental, Infe and General Hospi 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.