(24 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, meet all of the requirements of ASTM D 3577, Type 2. 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 intended to be worn by operating room personnel to protect a surgical wound from contamination.
Here's a breakdown of the acceptance criteria and study information based on the provided documents.
The document describes the regulatory submission for Elite™ Powder Free Polyurethane Synthetic Surgical Gloves. The "study" here refers to the testing performed to demonstrate that the device meets existing standards, rather than a clinical trial for efficacy against a disease.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Specification) | Reported Device Performance |
|---|---|
| ASTM D 3577 (General Requirements) | Meets ASTM D 3577 |
| ASTM D 3577, Type 2 (Physical Properties) | Meets ASTM D 3577, Type 2 |
Note: The document explicitly states that the "Elite™ Powder Free Polyurethane Synthetic Surgical Gloves meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves" and that the product "meets all of the requirements of ASTM D 3577, Type 2." These are the primary performance criteria cited.
2. Sample Size Used for the Test Set and Data Provenance
The provided document (a 510(k) summary and FDA letter) does not specify the exact sample size used for destructive physical testing or the country of origin. Regulatory submissions for devices like surgical gloves typically involve testing batches according to the ASTM standards. The data would be prospective, as it's generated specifically for the submission to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. For devices like surgical gloves, the "ground truth" is established by the specifications defined in recognized consensus standards (e.g., ASTM D 3577). The "experts" in this context are the committees and bodies that develop and maintain these international standards, and the testing laboratories that perform the specified tests according to documented and validated methods. It's not about expert clinical consensus on individual cases.
4. Adjudication Method for the Test Set
N/A. As mentioned above, the "ground truth" is defined by the ASTM D 3577 standard. Testing is performed according to the methods outlined in this standard, and the results are compared against the pass/fail criteria. There isn't an "adjudication method" in the sense of reconciling divergent expert opinions on a clinical outcome.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is not applicable for this type of device. Surgical gloves are subject to performance testing against established physical and chemical standards, not comparative clinical effectiveness via human readers or interpreters.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A. This is not an AI/algorithm-driven device. Its performance is based purely on its physical and material properties.
7. The Type of Ground Truth Used
Expert Consensus (Standards): The ground truth is defined by the ASTM D 3577 standard. This standard, developed by technical experts, specifies the required dimensions, physical properties (e.g., tensile strength, elongation at break), and barrier integrity (e.g., freedom from holes) for rubber surgical gloves. Compliance with this standard indicates the device's fitness for its intended purpose.
8. The Sample Size for the Training Set
N/A. This is not an AI/machine learning device, so there is no concept of a "training set" for an algorithm. The gloves are manufactured and tested against predefined specifications.
9. How the Ground Truth for the Training Set Was Established
N/A. (See point 8).
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Elite™ Powder Free Polyurethane Synthetic Surgical Gloves Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 Telephone: 330-833-2811 330-833-6213 Fax:
Checklist
Section 21.0
- 510 (k) Summary [1]
- Ansell Perry Inc. [2] 1875 Harsh Avenue SE Massillon, Ohio 44646
Telephone: 330-833-2811 330-833-6213 Fax:
James R. Chatterton Contact: Telephone: 330-833-2811 330-833-6213 Fax:
September 10, 1997
- Elite™ Powder Free Polyurethane Synthetic Surgical Gloves [3] Trade Name: Surgical Gloves, Green Polyurethane Common Name: Surgeon's Glove Classification Name:
- Elite™ Powder Free Polyurethane Synthetic Surgical Gloves, meet all of the requirements of [4] ASTM D 3577, Type 2.
- Elite™ Powder Free Polyurethane Synthetic Surgical Gloves meet all the current specifications (5) for ASTM D 3577 Rubber Surgical Gloves.
- 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.
- 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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" surrounding it. The text is arranged in a circular fashion, following the curve of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY | | | |998
Mr. James R. Chatterton Vice President Regulatory Affairs, Technical Ansell Perry, Incorporated 1875 Harsh Avenue SE Massillon, Ohio 44646
K981392 Re : Elite Mark IV Sterile Powder-Free Trade Name: Polyurethane Synthetic Surgical Gloves (Green) Requlatory Class: I Product Code: KGO Dated: April 9, 1998 Received: April 17, 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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify *such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements 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
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Page 2 - Mr. Chatterton
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) 594-4692. 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 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:
INDICATIONS FOR USE
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Surgeon's Glove, powder free, polyurethane, green color Device Name: _
Indications For Use:
A device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
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Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Off) Heeze 1.milk for China 5. Tin PR
Divisional, Infection Control,
and General Hospital Devices
510(k) Number κ981372
D
Prescription Use Per 21 CFR 801.109 OR
Over-The-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).