(56 days)
A disposable device intended for medical purpose that is worn on the examiners hand to prevent contamination between patient and examiner.
Conform® No Powder (Protein Labeling Claim) examination gloves are a disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
The provided text describes the acceptance criteria and performance of "Conform® No Powder (Protein Labeling Claim)" examination gloves, a medical device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Standard / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 3578 | Meets ASTM D 3578 |
| Physical Properties | Meets ASTM D 3578 | Meets ASTM D 3578 |
| Freedom from holes | Meets ASTM D 3578; Meets ASTM D 5151 | Meets ASTM D 3578; Meets ASTM D 5151 |
| Powder-Free | Not more than 2 mg residue by mass; Meets described test in Attachment VI | Not more than 2 mg residue by mass; Meets described test in Attachment VI |
| Protein Label Claim | This latex glove contains 50 micrograms or less of total water extractable protein per gram. | This latex glove contains 50 micrograms or less of total water extractable protein per gram. |
| Primary Skin Irritation in Rabbits | Passes | Passes |
| Guinea Pig Sensitization | Passes | Passes |
| Hypoallergenic/Modified Draize | Passes in 200 human subjects | Passes in 200 human subjects |
2. Sample size used for the test set and the data provenance:
- Sample Size:
- For the Hypoallergenic/Modified Draize test, 200 human subjects were used.
- For other tests (Dimensions, Physical Properties, Freedom from holes, Powder-Free, Protein Label Claim, Primary Skin Irritation, Guinea Pig Sensitization), the sample sizes are not explicitly stated, but are implied to be sufficient for meeting the respective ASTM standards and internal tests.
- Data Provenance: Not explicitly stated, but the testing was conducted by Ansell Perry Inc. as part of their 510(k) submission to the FDA in the USA. It is implied to be prospective testing for the purpose of regulatory clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This document describes performance testing for a medical device (examination gloves) against established standards (ASTM) and biocompatibility tests. It does not involve "ground truth" derived from expert consensus in the same way an AI diagnostic device would.
- The "ground truth" is defined by the objective measurements and pass/fail criteria of the specified ASTM standards and biocompatibility tests.
- Therefore, the concept of "number of experts used to establish ground truth" and their qualifications is not directly applicable in the context of this device's evaluation. The experts would be the accredited laboratories and personnel performing the standardized tests.
4. Adjudication method for the test set:
- Not applicable in the traditional sense for an AI system. The device's performance is adjudicated by its adherence to the quantitative and qualitative requirements of the ASTM standards and biocompatibility tests.
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:
- No. This is not an AI diagnostic device, but rather a physical medical device (examination glove). Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI system. The performance evaluated is the standalone performance of the physical glove itself based on material properties and biological interaction.
7. The type of ground truth used:
- The "ground truth" for this device's performance is based on objective measurement against established industry standards (ASTM D 3578, ASTM D 5151), chemical analysis (for powder residue and protein content), and biological test outcomes (Primary Skin Irritation, Guinea Pig Sensitization, Hypoallergenic on human subjects).
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device evaluation.
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Image /page/0/Picture/0 description: The image shows the logo for Ansell Perry. The words "Ansell Perry" are written in a bold, sans-serif font. The word "Ansell" is in white on a black background, while the word "Perry" is in white on a black background. The logo is simple and modern.
Conform® No Powder (Protein Labeling Claim) Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44644 Telephone: 330-833-2811 330-833-6213 Fax:
-
SEP 1 9 1997
Checklist Section 21.0 -
510 (k) Summary [1]
-
[2] Ansell Perry Inc. 1875 Harsh Avenue SE Massillon, Ohio 44646
Telephone: 330-833-2811 Fax: 330-833-6213
Contact: James R. Chatterton Telephone: 330-833-2811 Fax: 330-833-6213
July 23, 1997
- [3] Trade Name: Conform® No Powder (Protein Labeling Claim) Common Name: Examination Gloves Classification Name: Patient Examination Glove
- [4] Conform® No Powder (Protein Labeling Claim) examination gloves, meet all of the requirements of ASTM D 3578.
- [ર] Conform® No Powder (Protein Labeling Claim) examination gloves meet all the current specifications for ASTM D 3578 Rubber Examination Gloves.
- (6) Conform® No Powder (Protein Labeling Claim) examination gloves are a disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
- [7] Conform® No Powder (Protein Labeling Claim) examination gloves are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| Characteristics | Standard |
|---|---|
| Dimensions | Meets ASTM D 3578 |
| Physical Properties | Meets ASTM D 3578 |
Ansell Perry Inc. · 1875 Harsh Avenue S.E. · P.O. Box 550 · Massillon, Ohio 44648-0550 · U.S.A. Telephone 330-833-2811 · Toll Free 800-321-9752 (USA only) · Telefax 330-833-5991
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Conform® No Powder (Protein Labeling Claim)
Ansell Perry
1875 Harsh Avenue SE
Massillon, Ohio 44644
| Telephone: | 330-833-2811 |
|---|---|
| Fax: | 330-833-6213 |
| Freedom from holes | Meets ASTM D 3578 Meets ASTM D 5151 |
|---|---|
| Powder-Free | Not more than 2 mg residue by mass. |
| Meets described test in Attachment VI | |
| Protein Label Claim | This latex glove contains 50 micrograms or less of total water extractable protein per gram. |
| Biocompatability | |
| Primary Skin Irritation in Rabbits | Passes |
| Guinea Pig Sensitization | Passes |
| Hypoallergenic/Modified Draize 200 human subjects | Passes |
[8] The performance test data of the non clinical tests are the same as mentioned immediately above.
[9] Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process.
[10] It is concluded that Conform® No Powder (Protein Labeling Claim) examination gloves are as safe, as effective, and perform as well as the glove performance standards referenced in Section 7 above and therefore meet:
ASTM listed standards, FDA hole requirements, and labeling claims for the product.
[11] This summary will include any other information reasonably deemed necessary by The FDA.
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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle design, with the eagle's head facing to the right. The eagle's body is represented by three curved lines, and its legs are depicted with two curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. James R. Chatterton vice President Regulatory Affairs/Technical Ansell Perry Incorporated 1875 Harsh Avenue, S.E. Massillon, Ohio 44646-9987
SEP 1 9 1997
Re: K972785 Conform No Powder (Protein Labeling Claim) Trade Name: Examination Gloves Requlatory Class: I Product Code: LYY Dated: July 23, 1997 Received: July 25, 1997
Dear Mr. Chatterton:
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 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 Requlations, Title 21, Parts 800 to 895. ਉ 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 regulation (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 regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531
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Page 2 - Mr. Chatterton
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 beqin marketinq 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 premarket notification" (21 CFR 807.97). Other qeneral 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,
Patacia Cucurite /for
Timothy A. Ulatowski 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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INDICATIONS FOR USE
| Applicant: | Ansell Perry Inc. |
|---|---|
| 510(K) Number (if known): | K972785 * |
| Device Name: | Patient Examination Glove, Powder Free with Protein Label Claim |
| Indications For Use: |
A disposable device intended for medical purpose that is worn on the examiners 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)
ins.hin
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K972785
Prescription Use Per 21 CFR 801.109
Over-The-Counter X
(Optional Format 1-2-96)
§ 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.