(97 days)
A powder-free 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.
POWDER-FREE NITRILE GLOVES, BLACK
This is a 510(k) premarket notification for "Powder-Free Nitrile Gloves, Black," which are Class I medical devices (patient examination gloves). The provided document is a substantial equivalence determination letter from the FDA.
Since this document is for a Class I medical device (gloves) and not an AI/ML-powered diagnostic device, many of the requested fields (such as those related to AI model performance, training sets, expert review, MRMC studies, etc.) are not applicable. The traditional "device performance" in this context refers to physical and chemical properties of the gloves, not accuracy in diagnostic tasks.
Here's the closest representation based on the information provided and typical requirements for such devices:
Acceptance Criteria and Study for Powder-Free Nitrile Gloves, Black
1. A table of acceptance criteria and the reported device performance
For patient examination gloves, key performance criteria typically relate to barrier integrity, physical properties, and biocompatibility. While the specific test results are not in this FDA letter, the substantial equivalence determination implies that the device met these criteria, likely by showing equivalence to a predicate device that has demonstrated compliance.
| Acceptance Criteria (Typical for Examination Gloves) | Reported Device Performance (Implied by Substantial Equivalence to Predicate) |
|---|---|
| Barrier Integrity | |
| Tensile Strength | Met or exceeded predicate device performance |
| Elongation at Break | Met or exceeded predicate device performance |
| Freedom from Holes and Leaks (AQL) | Met or exceeded predicate device performance (e.g., AQL 2.5 for water leak) |
| Physical Properties | |
| Dimensions (Length, Palm Width, Thickness) | Within specified range |
| Biocompatibility | |
| Cytotoxicity | Non-cytotoxic |
| Sensitization | Non-sensitizing |
| Irritation | Non-irritating |
Note: The FDA letter states "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination means that the new device performs at least as well as a legally marketed predicate device. The actual detailed test results demonstrating this equivalence are usually contained within the 510(k) submission itself, not in the FDA's final decision letter.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in this document. For physical and chemical testing of gloves, sample sizes are typically defined by international standards (e.g., ISO, ASTM) and involve statistical sampling from manufacturing lots.
- Data Provenance: Not specified, but generally refers to data obtained from laboratory testing of the manufactured gloves.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical product (glove), not a diagnostic device requiring expert interpretation for ground truth. Testing involves laboratory personnel following established protocols.
4. Adjudication method for the test set
- Not Applicable. No human interpretation or adjudication in the context of diagnostic tasks is involved. Testing relies on objective measurements.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or software device.
7. The type of ground truth used
- Objective Measurement/Standard Specifications: "Ground truth" for examination gloves typically comes from meeting defined physical, chemical, and biological specifications outlined in recognized standards (e.g., ASTM D6319 for Nitrile Examination Gloves, ISO 10993 for biocompatibility). For example, "freedom from holes" is assessed by a water leak test, and tensile strength by a materials testing machine.
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of a manufactured physical product like a glove, as it doesn't involve machine learning or diagnostic image analysis.
9. How the ground truth for the training set was established
- Not Applicable.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Lau Siong Hut GM Operation HL Rubber Industries SDN BHD Lot 10, Kawasan, Perindustrian Dioh Kuala Pilah, Negeri Sembilan Malaysia 72000
MAY 2 0 2010
Re: K100369
Trade/Device Name: Powder - Free Nitrile Gloves, Black Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: April 1, 2010 Received: April 22, 2010
Dear Mr. Siong Hut:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2- Mr. Lau Siong Hut
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.html for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. .
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
hr fo.
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K100369
Device Name: POWDER-FREE NITRILE GLOVES, BLACK
Indications For Use:
A powder-free 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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use V (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off) 05/20/10
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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1<100369 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.