(44 days)
This glove Is disposable and is intended for medioal purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Smart Glove Latex Patternt Examination Gloves Powderfree, 50 mogm or less water extractable protein.
Here's a breakdown of the requested information, based on the provided document:
Observation: The provided document is a 510(k) clearance letter for an examination glove, not a document describing a medical device that utilizes an algorithm or AI. Therefore, most of the requested information regarding acceptance criteria, study data, expert involvement, and AI performance metrics is not applicable.
However, I can extract information related to the device and its intended use, which are analogous to reporting some "acceptance criteria" through regulatory compliance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Regulatory Compliance) | Reported Device Performance |
|---|---|
| Device Type: Examination Glove | Smart Glove Latex Patternt Examination Gloves Powderfree |
| Protein Content Labeling Claim: | 50 µg/gm or less water extractable protein |
| Intended Use: | Disposable; for medical purposes; worn on examiner's hand to prevent contamination between patient and examiner. |
| Regulatory Class: I | Met regulatory class I requirements |
| Compliance with GMP regulation (21 CFR Part 820): | Assumed; compliance verified through periodic GMP inspections. |
| Substantial Equivalence: | Determined by FDA to be substantially equivalent to devices marketed prior to May 28, 1976. |
The following sections are Not Applicable (N/A) to this document, as it pertains to a medical device (examination glove) without an algorithmic or AI component.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This information is not relevant for the regulatory clearance of a physical examination glove. Studies for such devices typically involve mechanical properties, biocompatibility, and chemical analyses, not performance against a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. Ground truth establishment by experts is not applicable for this type of device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication is not applicable as there is no test set in the context of an algorithm's output.
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
- N/A. This device does not involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. Ground truth, in the context of AI or diagnostic performance, is not applicable here. The "truth" for this device would be its physical and chemical properties and its ability to meet its intended use.
T8. The sample size for the training set
- N/A. Training sets are for machine learning models, which are not involved here.
9. How the ground truth for the training set was established
- N/A. There is no training set or AI model for which to establish ground truth. Data for glove testing would typically come from lab-based material characterization and sterility testing, if applicable.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 9 1997
Mr. Foo Knon Pu &J Medical Product SND BHD Lot 723, Batū 5 172, Jālan Kapar, 42100 Klang, Selangor Darul Ehsan MALAYSIA
Re : K971403 SMART - GLOVE® Powder-Free Latex Trade Name: Examination Glove with Protein Content Labeling Claim Requlatory Class: I Product Code: Lyy Dated: April 5, 1997 Received: April 15, 1997
Dear Mr. Foo Knon Pu:
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, 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 Regulations, Title 21, Parts 800 to 895. ಿಗೆ 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 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
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Page 2 - Mr. Foo Knon Pu
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 debtition in your of your device to a legally marketed bubblance device results in a classification for your device and thus, permits your device to proceed to the market. enab, pormal ( regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) Additionally, for questions on the promotion and 594-4692. 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). Mibbianant of Iornation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 for (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
K. Collaitrust
Timotiy Director
Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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MEDICAL PRODUCTS (M) SDN. BHD.
(Company No. 176287 H)
| INDICATIONS FOR USE |
|---|
| --------------------- |
Indication For Use Statement.
SJ MEDICAL PRODUCTS (M) SDN BHD Applicant :
: K 971403 510K ( Number )
. .
Device Name
3.0
Smart Glove Latex Patternt Examination Gloves Powderfree, 50 mogm or less water extractable protein.
Indication for Use: This glove Is disposable and is intended for medioal purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office Of Device Evaluation ( ODE )
Olin S. hin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number KG71403
Proscription Use (Per 21 CFR 801.109) OR
Over - The - Counter Use
19ption Porner 1-2-96)
Lot 723, Batu 51/2, Jalan Kapar, 42100 Klang, Selangor Darul Ehsan. Tel: 603-3915042/3/4 Fax: 603-3915041
§ 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.