(169 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.
Latex Exam Glove, Powder Free with Protein and Hypoallergenic Labeling. 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 provided document is a 510(k) summary for a Latex Exam Glove, not a complex AI device; therefore, many of the requested categories (like MRMC study, training set, AI vs. human performance) are not applicable. The document focuses on demonstrating substantial equivalence to a predicate device through adherence to established ASTM standards and biological testing.
Here's the information derived from the provided text, structured to best fit your request:
Acceptance Criteria and Device Performance for Latex Exam Glove
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Standard | Reported Device Performance (Means and/or Results) |
|---|---|
| ASTM D 3578-95 | Met or exceeded |
| ASTM D 5712 (Protein Content, mg/g against BSA): | |
| Internal Surface | 11 +/- 4 |
| External Surface | 12 +/- 4 |
| FDA Water Leak Test | AQL 4.0 |
| Primary Skin Irritation Test | Met or exceeded |
| Dermal Sensitization Study | Met or exceeded |
| Biocompatibility (Repeated Insult Patch) | Met or exceeded |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- For the Biocompatibility (Repeated Insult Patch) test, 200 subjects were used.
- For other tests (ASTM D 3578-95, ASTM D 5712, FDA Water Leak Test, Primary Skin Irritation Test, Dermal Sensitization Study), specific sample sizes are not explicitly stated in the provided text, but these are typically standardized for such tests.
- Data Provenance: The document does not specify the country of origin of the data. The tests are reported as being conducted for a company registered in Malaysia (Evergrade Healthcare Products Sdn Bhd) based on the address provided in the FDA letter. The study type is prospective in the sense that the tests were conducted specifically to demonstrate compliance for this device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This is not applicable for a medical device like a latex exam glove. The "ground truth" for these types of devices is established through adherence to recognized international and national standards (ASTM) and accepted biological testing protocols, not through expert consensus on qualitative assessments.
4. Adjudication Method for the Test Set
Not applicable. Testing involves objective measurements and adherence to pass/fail criteria outlined in the standards, rather than expert adjudication.
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 a medical device, not an AI or imaging diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for this device involves:
- Standards Compliance: Adherence to established performance specifications outlined in ASTM D 3578-95 and ASTM D 5712.
- Biological Endpoints: Objective results from biocompatibility testing (primary skin irritation, dermal sensitization, repeated insult patch test) measuring the biological response to the device.
- Physical Properties: Measurable physical properties like water leak integrity (FDA Water Leak Test AQL 4.0) and protein content.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established
Not applicable.
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MAR 1 3 1998
JANNA TUCKER & ASSOCIATES
973664 510(K) SUMMARY
19001 S. Richfield #185 Green Valley, AZ 85614 Telephone: (520) 625-2904 Fax: (520) 625- 391
Janna Tucker & Associates Submitted By: 19001 S. Richfield #185 Green Valley, AZ 85614 520-625-2904 Phone: FAX: 510-625-3908
Contact Person:
Date of Submission: August 19, 1997
Latex Exam Glove, Powder Free with Device Name: Protein and Hypoallergenic Labeling
Classification Name: Latex Exam Glove, 80LYY
(Various Labels) Latex Exam Glove, Powder Free, with Protein and Proprietary Name: Hypoallergenic Labeling
Janna P. Tucker, Official Correspondent of Evergrade
This device will be marketed to healthcare professionals at dentists Labels/Labeling: and doctor's offices, laboratories, clinics and hospitals through its intended use.
Healthcare Products SDN. BHD.
A patient examination glove is a disposable device intended for Intended Use: medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Substantial Equivalence:
The above device is equivalent to those in commercial distribution. These latex gloves are to be worn as a protective device on the examiners hand or finger.
Both in its intended use and/or physical characteristics, this device is equivalent to devices currently marketed by U.S. companies. It is Substantially Equivalent to the device manufactured by Sinochem Ningbo, K955918, Latex Exam Gloves, powder-free, with Protein Labeling and Hypoallergenic Claims.
EXHIBIT H
Page 45 of 46
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Test Results (Means
and/or Results):
This device has met or exceeded the following standards/tests:
ASTM D 3578-95, Standard Specification for Rubber Exam Gloves ASTM D 5712, RRIM Modified Lowry Microassay: Protein Content, mg/g (against BSA): Internal Surface: 11 +/- 4; External Surface: 12 +/- 4 FDA Water Leak Test AQL 4.0 Primary Skin Irritation Test Dermal Sensitization Study Biocompatibility [Repeated Insult Patch (200 Subjects)]
Conclusions:
This device is substantially equivalent to the Sinochem Ningbo device approved under 510(k) K955918.
EXHIBIT M
Page 46 of 46
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 3 1998
Evergrade Healthcare Products Sdn Bhd C/O Janna Tucker & Associates 19001 S. Richfield #185 85614 Green Valley, Arizona
Re : K973664 Latex Examination Glove, Powder-Free, Trade Name: ade Name: (50 Micro grams or less) Requlatory Class: I Product Code: LYY February 4, 1998 Dated: February 10, 1998 Received:
Dear Ms. Tucker:
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 regulations affecting your device can be found in the Code of Federal Requiations, Title 21, Parts-800-to-895. A- ---------substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action.
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Page 2 - Ms. Tucker
concerning your device in the Federal Reqister. 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) 594-4618. 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 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
Timoth 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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INDICATIONS FOR USE
| Applicant: | EVERGRADE HEALTHCARE PRODUCTS, SDN. BHD. |
|---|---|
| 510(k) Number (if known): | K973664 |
| Device Name: | Latex Exam Glove, Powder Free, with Protein |
Indications For Use:
n and Hypoallergenic Labeling
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Qiin S. him
(Division Sign-Off) Division of Dental, Infection Contr and General Hospital D 510(k) Number
Prescription Use Per 21 CFR 801.109 OR
Over-The-Counter X
(Optional Format 1-2-96)
EXHIBIT B
Page 2 of 46
§ 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.