(49 days)
A device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Encore Mark IV Powder Free Surgical Gloves, meet all of the requirements of ASTM D 3577, Type 1. Encore Mark IV Powder Free Surgical Gloves meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves. Encore Mark IV Powder Free Surgical Gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination. Encore Mark IV Powder Free Surgical Gloves are summarized with the following technological characteristics compared to ASTM or equivalent standards.
The medical device discussed in the provided text is "Encore Mark IV Powder Free Surgical Gloves". This 510(k) summary focuses on demonstrating that the device is substantially equivalent to existing standards for surgical gloves, rather than presenting a study of its performance against acceptance criteria in a clinical setting in the way a diagnostic AI device would. Therefore, much of the requested information regarding AI device studies is not applicable.
Here's an interpretation based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Encore Mark IV Powder Free Surgical Gloves are based on established ASTM (American Society for Testing and Materials) standards and FDA requirements for medical gloves.
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance (Encore Mark IV Powder Free Surgical Gloves) |
|---|---|---|
| Dimensions | Meets ASTM D 3577 | Meets ASTM D 3577 |
| Physical Properties | Meets ASTM D 3577, Type 1 | Meets ASTM D 3577, Type 1 |
| Freedom from holes | Meets ASTM D 3577 | Meets ASTM D 5151 (and implicitly ASTM D 3577) |
| Powder-Free | Meets ASTM D 6124 | Not more than 2 mg residue by mass |
| Biocompatibility | ||
| Primary Skin Irritation | (Likely a Pass/Fail criterion) | Passes |
| Guinea Pig Sensitization | (Likely a Pass/Fail criterion) | Passes |
Note: The document states "Encore Mark IV Powder Free Surgical Gloves meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves," which acts as an overarching statement for many physical and dimensional properties.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the testing of the Encore Mark IV gloves against the ASTM standards. These tests are typically conducted on representative samples from manufacturing batches. The data provenance is derived from internal testing by Ansell Perry to ensure compliance with the specified ASTM standards. It's retrospective in the sense that the tests are performed on manufactured gloves to confirm they meet predefined standards. There is no information on country of origin for the data provided beyond Ansell Perry being an American company.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable in the context of this device. The "ground truth" for the device's performance is established by the specified ASTM standards themselves. These standards are developed by consensus among experts in the field of materials science, manufacturing, and medical device regulation. The individual who performs the tests to determine compliance would be a trained laboratory technician or engineer, adhering to the methodologies outlined in the ASTM standards.
4. Adjudication Method for the Test Set
This is not applicable as the "acceptance criteria" are quantitative measurements against an established standard (e.g., maximum residue, minimum tensile strength, etc.) rather than subjective expert consensus. The results are typically pass/fail based on direct measurement and comparison to the standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for comparing the diagnostic performance of human readers, potentially with and without AI assistance, on a set of cases. This device is a surgical glove, which is a physical product, not a diagnostic tool where human interpretation is involved in its function.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This concept is not applicable. There is no algorithm or AI component in the Encore Mark IV Powder Free Surgical Gloves.
7. The Type of Ground Truth Used
The ground truth used for evaluating this device's performance against its acceptance criteria is established industry and regulatory standards. Specifically:
- ASTM D 3577: Standard Specification for Rubber Surgical Gloves.
- ASTM D 5151: Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D 6124: Standard Test Method for Residual Powder on Medical Gloves.
- Biocompatibility tests (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization) follow established biological evaluation methods for medical devices.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of a physical medical device like a surgical glove. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set for this product.
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Encore Mark IV Powder Free Surgical Gloves Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 Telephone: 330-833-2811 330-833-6213 Fax:
FEB - 9 1998
Checklist Section 21.0
- [1] 510 (k) Summary
- [2] Ansell Perry Inc. 1875 Harsh Avenue SE Massillon, Ohio 44646
Telephone: 330-833-2811 Fax: 330-833-6213
James R. Chatterton Contact: Telephone: 330-833-2811 Fax: 330-833-6213
December 18, 1997
- Encore Mark IV Powder Free Surgical Gloves [3] Trade Name: Common Name: Surgical Gloves Classification Name: Surgeon's Glove
- [4] Encore Mark IV Powder Free Surgical Gloves, meet all of the requirements of ASTM D 3577, Type 1.
- Encore Mark IV Powder Free Surgical Gloves meet all the current specifications for ASTM D [ર] 3577 Rubber Surgical Gloves.
- [6] Encore Mark IV Powder Free Surgical Gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
- [7] Encore Mark IV Powder Free Surgical Gloves are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| Characteristics | Standard |
|---|---|
| Dimensions | Meets ASTM D 3577 |
| Physical Properties | Meets ASTM D 3577, Type |
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| Encore Mark IV Powder Free Surgical GlovesAnsell Perry1875 Harsh Avenue SEMassillon, Ohio 44646 | ||
|---|---|---|
| Telephone: | 330-833-2811 | |
| Fax: | 330-833-6213 | |
| Freedom from holes | Meets ASTM D 3577 | Meets ASTM D 5151 |
| Powder-Free | Meets ASTM D 6124 | Not more than 2 mg residue by mass |
| Meets described test in Attachment VI | ||
| Biocompatability | ||
| Primary Skin Irritation in Rabbits | Passes | |
| Guinea Pig Sensitization | Passes |
- 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. [9]
- It is concluded that Encore Mark IV Powder Free Surgical Gloves are as safe, as effective, and [10] 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 the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FFB - 8 1958
Mr. James R. Chatterton Vice President Regulatory Affairs/Technical Ansell Perry 1875 Harsh Avenue, S.E. Massillon, Ohio 44646-7199
K974783 Re : Encore Mark IV Powder Free Latex Surgical Trade Name: Gloves, Polymer Coated Requlatory Class: ने Product Code: KGO Dated: December 18, 1997 December 22, 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 requlations 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 Requlation (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 regulation may result in regulatory In addition, FDA may publish further announcements action. 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
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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 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 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,
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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3.0 Indications for Use Statement:
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INDICATIONS FOR USE
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Surgeons Glove, latex polymer coated, powder free Device Name:
Indications For Use:
A device made of natural 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)
Qia S. Lin
(Division Sign-Off) Division of Dental, Inf and General Hospit : : (k) Number
Prescription Use Per 21 CFR 801.109 OR
Over-The-Counter
Counter
§ 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).