(85 days)
A device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Derma Prene® Powder-Free Synthetic Surgical Gloves, meet all of the requirements of ASTM D 3577, Type 2. Derma Prene® Powder-Free Synthetic Surgical Gloves meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves. Derma Prene® Powder-Free Synthetic Surgical Gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination. Derma Prene® Powder-Free Synthetic Surgical Gloves are summarized with the following technological characteristics compared to ASTM or equivalent standards.
The provided text describes the acceptance criteria and performance of the Derma Prene® Powder-Free Synthetic Surgical Gloves. It does not describe a study involving AI, human readers, or clinical outcomes data in the way a typical medical device AI study would. The acceptance criteria and performance are based on established ASTM standards for surgical gloves and biocompatibility tests.
Here's an analysis based on the provided text, addressing the points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Standard | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 3577 | Meets ASTM D 3577 |
| Physical Properties | Meets ASTM D 3577, Type 2 | Meets ASTM D 3577, Type 2 |
| Freedom from holes | Meets ASTM D 3577 | Meets ASTM D 3577 |
| Freedom from holes (alternative) | Meets ASTM D 5151 | Meets ASTM D 5151 |
| Powder-Free | Meets ASTM D 6124 | Meets ASTM D 6124 |
| Powder-Free (residue by mass) | Not more than 2 mg residue | Meets described test in Attachment VI (implies <= 2 mg) |
| Primary Skin Irritation in Rabbits | (Implied standard for "Passes") | Passes |
| Guinea Pig Sensitization | (Implied standard for "Passes") | Passes |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for testing each characteristic. The tests are described as "non clinical tests" and the data provenance is not explicitly stated in terms of country of origin or retrospective/prospective nature, though it's implied to be laboratory testing in support of the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the measurements are against objective, quantitative standards (ASTM D 3577, D 5151, D 6124) and biocompatibility tests (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization). There is no mention of human experts establishing a "ground truth" for the device's performance against these standards, as the standards themselves define the criteria.
4. Adjudication method for the test set
Not applicable. The performance is measured directly against predefined ASTM standards and test methods. There is no mention of adjudication for these types of objective physical or chemical 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
Not applicable. This is a surgical glove device, not an AI-powered diagnostic tool. Therefore, no MRMC study involving human readers or AI assistance was performed or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used
The "ground truth" for the device's performance against the acceptance criteria is defined by established industry standards (ASTM D 3577, D 5151, D 6124) and recognized biocompatibility testing methods. For example, "Meets ASTM D 3577" or "Passes" for biocompatibility tests are the ultimate ground truth for this device's regulatory submission.
8. The sample size for the training set
Not applicable. This is a manufactured product (surgical glove) and 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, as there is no training set for this device.
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5 1998 JUN
Checklist Section 21.0
Derma Prene® Powder-Free Synthetic Surgical Gloves Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 330-833-2811 Telephone: 330-833-6213 Fax:
- [1] 510 (k) Summary
- [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
March 12, 1998
- [3] Trade Name: Derma Prene® Powder-Free Synthetic Surgical Gloves Common Name: Surgical Gloves Classification Name: Surgeon's Glove
- [4] Derma Prene® Powder-Free Synthetic Surgical Gloves, meet all of the requirements of ASTM D 3577, Type 2.
- [ર] Derma Prene® Powder-Free Synthetic Surgical Gloves meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves.
- Derma Prene® Powder-Free Synthetic Surgical Gloves are sterile disposable devices intended to [୧] be worn by operating room personnel to protect a surgical wound from contamination.
- Derma Prene® Powder-Free Synthetic Surgical Gloves are summarized with the following [7] technological characteristics compared to ASTM or equivalent standards.
| Characteristics | Standard |
|---|---|
| Dimensions | Meets ASTM D 3577 |
| Physical Properties | Meets ASTM D 3577, Type 2 |
CA
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Derma Prene® Powder-Free Synthetic Surgical Gloves Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 Telephone: 330-833-2811 330-833-6213 Fax:
Freedom from holes
Meets ASTM D 3577 Meets ASTM D 5151
Powder-Free Meets described test in Attachment VI Meets ASTM D 6124 Not more than 2 mg residue by mass.
| Biocompatability | |
|---|---|
| Primary Skin Irritation in Rabbits | P |
| Guinea Pig Sensitization | P |
asses asses
- The performance test data of the non clinical tests are the same as mentioned immediately above. [8]
- Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process. િ
- It is concluded that Derma Prene® Powder-Free Synthetic Surgical Gloves are as safe, as [10] 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.
- This summary will include any other information reasonably deemed necessary by The FDA. [11]
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN B 1098
Mr. James R. Chatterton · Vice President Regulatory Affairs/Technical Ansell Perry, Incorporated 1875 Harsh Avenue SE Massillon, Ohio 44646
Re: K980929 Derma Prene® Powder-Free Synthetic Surgical Trade Name: Gloves-Green Regulatory Class: I KGO Product Code: Dated: March 12, 1998 Received: March 12, 1998
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 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). 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. ಗಿ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 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
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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 regulations.
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html" .
Sincerely yours,
Timothy A. Ulatowski
Timoty 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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3.0 Indications for Use Statement:
INDICATIONS FOR USE
| Applicant: | Ansell Perry |
|---|---|
| 510(K) Number (if known): | K980929 |
| Device Name: | -Derma Prene@ Surgeon's Glove, powder free, polychloroprene - green |
| Indications For Use: |
A device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Olin S. him
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
.iption Use Per 21 CFR 801.109 OR
Over-The-Counter
X
_
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).