(72 days)
A device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Sensi-Derm® Latex Surgical Gloves meet all of the requirements of ASTM D 3577, Type 1. Sensi-Derm® Latex Surgical Gloves meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves. Sensi-Derm® Latex Surgical Gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination. Sensi-Derm® Latex Surgical Gloves are summarized with the following technological characteristics compared to ASTM or equivalent standards.
This is a surgical glove, rather than an AI/ML device, so the requested information regarding AI/ML device performance criteria, training sets, expert adjudication, and MRMC studies is not applicable. The provided text describes the performance of "Sensi-Derm® Latex Surgical Gloves" against established ASTM (American Society for Testing and Materials) standards.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 3577 | Meets ASTM D 3577 |
| Physical Properties | ASTM D 3577, Type 1 | Meets ASTM D 3577, Type 1 |
| Freedom from holes | ASTM D 3577 | Meets ASTM D 3577 |
| Freedom from holes | ASTM D 5151 | Meets ASTM D 5151 |
| Biocompatibility: Primary Skin Irritation in Rabbits | (Implied "Passes") | Passes |
| Biocompatibility: Guinea Pig Sensitization | (Implied "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 against ASTM D 3577, D 5151, or for the biocompatibility tests (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization). The data provenance is not explicitly stated in terms of country of origin, but the testing would have been conducted by or for Ansell Perry Inc., based in Massillon, Ohio, USA, to meet US regulatory requirements. The tests are descriptive of the product's inherent physical and biological properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is a surgical glove, and its performance is evaluated against established ASTM standards and biocompatibility protocols, not through expert-driven ground truth establishment in the same manner as an AI/ML diagnostic device. The "ground truth" here is the adherence to these predefined physical and biological standards.
4. Adjudication method for the test set:
Not applicable. The evaluation is based on objective measurements and observations against pre-defined ASTM standards and biocompatibility test outcomes. There is no expert adjudication process described for interpreting subjective results in the way one would see for image analysis or clinical diagnosis.
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 physical medical device (surgical glove), not an AI/ML diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device (surgical glove), not an algorithm.
7. The type of ground truth used:
The "ground truth" for the device's performance is objective measurements and observations that demonstrate compliance with established ASTM (American Society for Testing and Materials) standards for dimensions, physical properties, and freedom from holes, as well as results from standard biocompatibility tests (Primary Skin Irritation in Rabbits and Guinea Pig Sensitization).
8. The sample size for the training set:
Not applicable. This is a physical medical device (surgical glove), not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This is a physical medical device (surgical glove), not an AI/ML algorithm that requires a training set and associated ground truth establishment.
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K980880
Sensi-Derm® Latex Surgical Gloves Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 Telephone: 330-833-2811 330-833-6213 Fax:
MAY 20, 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
Contact: James R. Chatterton 330-833-2811 Telephone: Fax: 330-833-6213
March 3, 1998
- [3] Trade Name: Sensi-Derm® Latex Surgical Gloves Common Name: Surgical Gloves Classification Name: Surgeon's Glove
- Sensi-Derm® Latex Surgical Gloves meet all of the requirements of ASTM D 3577, Type 1. [4]
- [2] Sensi-Derm® Latex Surgical Gloves meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves.
- [୧] Sensi-Derm® Latex Surgical Gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
- [7] Sensi-Derm® Latex 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 |
83
129
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Sensi-Derm® Latex 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]
- Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process. [୨]
- It is concluded that Sensi-Derm® Latex Surgical Gloves are as safe, as effective, and perform as [10] 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 1998
Mr. James R. Chatterton Vice President Regulatory Affairs/Technical Ansell Perry, Incorporated 1875 Harsh Avenue SE Massillon, Ohio 44646
Re : K980880 Sensi-Derm® Latex Surgical Gloves Trade Name: (Powdered) , Brown Color Regulatory Class: I Product Code: KGO March 3, 1998 Dated: Received: March 9, 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. ਜੋ 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 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 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 enroduct Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as The FDA described in your 510(k) premarket notification. 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Timothy 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, Inc. |
|---|---|
| 510(K) Number (if known): | K980880 * |
| Device Name: | Surgeons Glove, Latex Brown Color (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)
Chis S. him
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K980850
Prescription Use Per 21 CFR 801.109 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).