(40 days)
A device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Medi-Grip (Beige 43) Surgical Gloves meet all of the requirements of ASTM D 3577, Type 1. Medi-Grip (Beige 43) Surgical Gloves meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves. Medi-Grip (Beige 43) Surgical Gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
This document describes the acceptance criteria and the study proving the device meets those criteria for the Medi-Grip (Beige 43) Surgical Gloves.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| 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 and ASTM D 5151 | Meets ASTM D 3577 and ASTM D 5151 |
| Biocompatibility: Primary Skin Irritation in Rabbits | Passes (implicitly, as it meets the standard) | Passes |
| Biocompatibility: Guinea Pig Sensitization | Passes (implicitly, as it meets the standard) | Passes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the specific performance tests (dimensions, physical properties, freedom from holes, biocompatibility). It only states that the device "meets all of the requirements of ASTM D 3577, Type 1" and "meets all the current specifications for ASTM D 3577 Rubber Surgical Gloves," and also "Meets ASTM D 5151" for freedom from holes. The biocompatibility tests "Passed."
The data provenance is not explicitly stated in terms of country of origin, but it is implied to be from tests conducted to meet U.S. ASTM standards. The data is non-clinical test data. It is considered retrospective in the context of this submission, as the tests were performed prior to the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. For this type of device (surgical gloves), the ground truth is established by standardized performance tests (ASTM standards) with objective measurements, not by expert consensus or interpretation of images. The "experts" involved are presumed to be the appropriately qualified personnel who conduct laboratory testing according to ASTM protocols.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation). For objective performance tests against pre-defined specifications, multiple readings/tests are typically averaged or analyzed against statistical limits defined by the standard, but there is no "adjudication" in the sense of reconciling differing expert opinions.
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. These studies are typically used for diagnostic or interpretive devices involving human readers. For surgical gloves, the performance is assessed through objective physical and biocompatibility testing.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance evaluation for the Medi-Grip Surgical Gloves is a standalone evaluation of the device itself against established standards. There is no algorithm or human-in-the-loop component for surgical glove performance testing. The "non-clinical tests" (Sections 7 and 8) represent the standalone performance evaluation.
7. The Type of Ground Truth Used
The ground truth used is based on pre-defined, objective performance specifications and test methods outlined in industry standards, specifically:
- ASTM D 3577: Standard Specification for Rubber Surgical Gloves
- ASTM D 5151: Standard Test Method for Detection of Holes in Medical Gloves
- Biocompatibility standards related to primary skin irritation (rabbits) and guinea pig sensitization.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training set" concept is not relevant to the evaluation of surgical gloves.
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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Medi-Grip (Beige 43) Surgical Gloves Ansell Perry 1875 Harsh Avenue SE MAR 25 1998 Massillon, Ohio 44646 Telephone: 330-833-2811 330-833-6213 Fax:
MAR 25 1998
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
Contact: James R. Chatterton 330-833-2811 Telephone: Fax: 330-833-6213
February 10, 1998
- Medi-Grip (Beige 43) Surgical Gloves [3] Trade Name: Common Name: Surgical Gloves Classification Name: Surgeon's Glove
- Medi-Grip (Beige 43) Surgical Gloves meet all of the requirements of ASTM D 3577, Type 1. [4]
- Medi-Grip (Beige 43) Surgical Gloves meet all the current specifications for ASTM D 3577 [ર] Rubber Surgical Gloves.
- Medi-Grip (Beige 43) Surgical Gloves are sterile disposable devices intended to be worn by [୧] operating room personnel to protect a surgical wound from contamination.
- Medi-Grip (Beige 43) Surgical Gloves are summarized with the following technological [7] characteristics compared to ASTM or equivalent standards.
| Characteristics | Standard |
|---|---|
| Dimensions | Meets ASTM D 3577 |
| Physical Properties | Meets ASTM D 3577, Type 1 |
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Medi-Grip (Beige 43) 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
Biocompatability Primary Skin Irritation in Rabbits Guinea Pig Sensitization
Passes Passes
- The performance test data of the non clinical tests are the same as mentioned immediately above. [8]
- [9] Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process.
- It is concluded that Medi-Grip (Beige 43) Surgical Gloves are as safe, as effective, and perform [10] 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 circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 25 1998
Mr. James R. Chatterton Vice President Regulatory Affairs/Technical Ansell Perry Incorporated 1875 Harsh Avenue S.E. Massillon, Ohio 44646
Re : K980564 Medi-Grip (Beige 43) Powdered Latex Trade Name: Surgical Gloves Requlatory Class: I Product Code: KGO February 10, 1998 Dated: Received: February 13, 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, Druq, 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 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 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 regulation (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
hv 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
| Annlicant's | A collected and------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | -------------- | ||||
|---|---|---|---|---|---|---|
| 510(K) Number (if known): | CARANA | 1 | ||||
Device Name: Surgeons Glove, Latex (powdered)
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) -------
Qilin S. Lin
(Division Sign-Off)
(Division of Dental, Infection Control,
and General Hospital, Infection Control, and General Hospital Infection 510(k) Number
Prescription 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).