(88 days)
A device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Elite™ Powder Free Polyurethane Synthetic Surgical Gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
Here's an analysis of the provided text, focusing on acceptance criteria and supporting studies for the Elite™ Powder Free Polyurethane Synthetic Surgical Gloves:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (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 5151 | Passes |
| Powder-Free | Meets ASTM D 6124 and not more than 2 mg residue by mass | Meets described test in Attachment VI, Not more than 2 mg residue by mass. |
| Biocompatibility - Primary Skin Irritation | Passes described test in Attachment VI | Passes |
| Biocompatibility - Guinea Pig Sensitization | Passes described test in Attachment VI | Passes |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the sample sizes used for the tests outlined (e.g., for freedom from holes, physical properties, biocompatibility). It only references that the device "meets" or "passes" the specified ASTM standards or internal tests. The data provenance is also not specified; it is implied to be from internal testing by Ansell Perry, Inc., in the United States, but no specific country of origin for the data is mentioned. The studies are assumed to be prospective, as they are part of a submission for market clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish a "ground truth" for the test set in the way one might for diagnostic AI. The acceptance criteria are based on established ASTM standards for surgical gloves. The compliance with these standards would typically be assessed by internal quality control personnel and verified by a regulatory body like the FDA, rather than clinical experts establishing a ground truth for a diagnostic outcome.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring adjudication of expert opinions for a diagnostic outcome. The tests involve objective measurements against predefined standards (e.g., dimensions, physical properties, hole detection).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical glove, not a diagnostic or decision-support AI tool where human reader performance would be a relevant metric.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, implicitly. The performance evaluation presented is a standalone assessment of the device (the surgical glove) against established physical and chemical standards. There is no "human-in-the-loop" component in the testing of the glove's basic physical properties, freedom from holes, or biocompatibility.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on established industry standards (ASTM) and defined test methods. For example:
- Dimensions and Physical Properties: Assessed against the specifications outlined in ASTM D 3577.
- Freedom from Holes: Assessed against the specifications in ASTM D 5151.
- Powder-Free: Assessed against ASTM D 6124 and a quantitative limit of 2mg residue by mass.
- Biocompatibility: Assessed against defined primary skin irritation and guinea pig sensitization tests.
8. The Sample Size for the Training Set
Not applicable. This document describes the testing and clearance of a medical device (surgical gloves), not an artificial intelligence algorithm or 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 submission.
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Elite™ Powder Free Polyurethane Synthetic Surgical Gloves Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 330-833-2811 Telephone: --330-833-6213 Fax:
Checklist Section 21.0
- 510 (k) Summary [1]
- [2] Ansell Perry Inc. 1875 Harsh Avenue SE Massillon, Ohio 44646
330-833-2811 Telephone: Fax: 330-833-6213
James R. Chatterton Contact: Telephone: 330-833-2811 Fax: 330-833-6213
September 10, 1997
- [3] Trade Name: Elite™ Powder Free Polyurethane Synthetic Surgical Gloves Common Name: Surgical Gloves Classification Name: Surgeon's Glove
- Elite™ Powder Free Polyurethane Synthetic Surgical Gloves, meet all of the requirements of [4] ASTM D 3577, Type 2.
- (૨) Elite™ Powder Free Polyurethane Synthetic Surgical Gloves meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves.
- Elite™ Powder Free Polyurethane Synthetic Surgical Gloves are sterile disposable devices [6] intended to be worn by operating room personnel to protect a surgical wound from contamination.
- Elite™ Powder Free Polyurethane 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 |
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Elite™ Powder Free Polyurethane Synthetic Surgical Gloves Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 330-833-2811 Telephone: Fax: 330-833-6213
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 Guinea Pig Sensitization
Freedom from holes
Passes Passes
- [8] The performance test data of the non clinical tests are the same as mentioned immediately above.
- (di Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process.
- It is concluded that Elite™ Powder Free Polyurethane 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/2 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 9 1997
Mr. James R. Chatterton Vice President Regulatory Affairs/Technical Ansell Perry, Incorporated 1875 Harsh Avenue, S.E. Massillon, Ohio 44646-7199
Re : K973461 Elite Powder Free Polyurethane Synthetic Trade Name: Surqical Glove Requlatory Class: I Product Code: KGO November 12, 1997 Dated: November 14, 1997 Received:
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 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 Requlations, 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 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 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
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Page 2 - Mr. Chatterton
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 regulation (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 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
K. Watro
Timothy | A. 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): | K97 3461 |
Surgeon's Glove, powder free, polyurethane Device Name:
Indications For Usc.
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)
Neeraj A. Mehelfer Chin S. Zin Ph.D
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices ×97346
510(k) Number.
OR
Over-The-Counter
Prescription Use Per 21 CFR 801,109
(Optional Format 1-2-96)
§ 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).