(185 days)
Latex Examination Glove, Powder Free Non Sterile is a disposable device and made of Natural Rubber Intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
Latex Examination Glove, Powder Free Non Sterile is a disposable device and made of Natural Rubber
This document is an FDA 510(k) clearance letter for a medical device: "Senstouch Latex Examination Glove, Powder Free Non Sterile."
Since this is a regulatory clearance for a medical device (a glove), the acceptance criteria and study information typically associated with complex AI/ML algorithms or software are not applicable here.
Medical gloves are cleared based on adherence to recognized standards for performance (like ASTM standards for physical properties, barrier integrity, and biocompatibility). The FDA determines substantial equivalence to a predicate device, meaning it performs as safely and effectively as a legally marketed device.
Here's why each point in your request is not applicable to this document:
- A table of acceptance criteria and the reported device performance: This document doesn't contain a detailed table of acceptance criteria and performance data. The clearance is based on satisfying general controls and demonstrating substantial equivalence to a predicate, often through adherence to recognized consensus standards.
- Sample size used for the test set and the data provenance: Not relevant for a glove clearance in this context. Testing would involve physical and chemical properties, not a "test set" of clinical data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not relevant. Ground truth in this context would refer to objective physical/chemical measurements against standards, not expert medical opinion on a diagnostic outcome.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not relevant. Adjudication methods are used for interpreting complex medical imaging or clinical data, not for material properties of a glove.
- If a multi reader multi case (MRMC) comparative effectiveness study was done... effect size of how much human readers improve with AI vs without AI assistance: Not relevant. This is for AI-assisted diagnostic tools, not basic medical devices like gloves.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant. Again, this applies to AI/ML algorithms.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not relevant in the typical sense. "Ground truth" for a glove would be objective measures of its physical integrity, tensile strength, freedom from holes, biocompatibility, etc., as per established material science standards.
- The sample size for the training set: Not relevant. There is no "training set" for a physical medical device like a glove.
- How the ground truth for the training set was established: Not relevant.
In summary: This document is an FDA 510(k) clearance letter confirming that the "Senstouch Latex Examination Glove, Powder Free Non Sterile" is substantially equivalent to existing devices. The detailed analytical and clinical study information requested is applicable to AI/ML-driven medical devices, not to a standard medical glove undergoing a 510(k) clearance process described here. The "study" here refers to the testing performed to demonstrate that the glove meets relevant ASTM or ISO standards for medical gloves, and a comparison to a predicate device.
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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 features an eagle-like symbol in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 2006
Mr. V. Nadarajan Manager, QA/RA PT. Mahakarya Inti Buana Jalan Sei Belumai Desa Dalu 10 A Dusun 1 No. 18 Tanjung Morawa-20362 SUMUT-INDONESIA
Re: K061233
Trade/Device Name: Senstouch Latex Examination Glove, Powder Free Non Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: October 3, 2006 Received: October 6, 2006
Dear Mr. Nadarajan
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Nadarajan
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): good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Clus
Chiu Lin. Ph.D. 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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Attachment 1
Indications for Use
510(k) Number (if known): [K061233](https://510k.innolitics.com/device/K061233)
Device Name: SENSTOUCH LATEX EXAMINATION GLOVE, POWDER FREE NON STERILE
Indications For Use: `Latex Examination Glove, Powder Free Non Sterile is a disposable device and made of Natural Rubber Intended for medical purpose 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) . . . . . .
:
the specificantly of the country of the
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ANDIOR ANDIOR 100 - 100 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Over-The-Counter Use (21 CFR 801 Subpart C)
: 上海
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Shula H. Murphy ks
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on of Anesthesiology, General Hospital, tion Control, Dental Devices
K 011233
§ 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.