(70 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 (Protein Labeling Claim) 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 (Protein Labeling Claim), meet all of the requirements of ASTM D 3577, Type 1. Encore Mark IV Powder Free Surgical Gloves (Protein Labeling Claim) meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves.
Acceptance Criteria and Device Performance Study for Encore Mark IV Powder Free Surgical Gloves
This document details the acceptance criteria and the study that demonstrates the Encore Mark IV Powder Free Surgical Gloves (Protein Labeling Claim) meet these criteria, as described in the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | 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 & Meets ASTM D 5151 | Meets ASTM D 3577 & Meets ASTM D 5151 |
| Powder-Free | Meets ASTM D 6124 (Not more than 2 mg residue by mass) | Meets ASTM D 6124 (Not more than 2 mg residue by mass) |
| Protein Label Claim | Not more than 50 micrograms of total water extractable protein per gram | Not more than 50 micrograms of total water extractable protein per gram |
| Biocompatibility: Primary Skin Irritation in Rabbits | Passes | Passes |
| Biocompatibility: Guinea Pig Sensitization | Passes | Passes |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify explict sample sizes for the test sets for each characteristic. The testing appears to be conducted on the product described, which are "Encore Mark IV Powder Free Surgical Gloves (Protein Labeling Claim)".
The data provenance is retrospective, as the submission is a 510(k) premarket notification, indicating that the product has been developed and tested. The country of origin of the data is not explicitly stated, but the submission is to the US FDA, implying testing conducted to US standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. For medical gloves, the "ground truth" is established by adherence to recognized industry standards (e.g., ASTM standards) and regulatory requirements (e.g., FDA hole requirements). These standards define objective, measurable criteria, and their application typically involves laboratory testing and interpretation of results by qualified technicians or engineers, rather than a panel of clinical experts establishing a "ground truth" through consensus in the way it would be for diagnostic imaging.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies where human interpretation or subjective assessment is involved to resolve discrepancies. For the objective performance characteristics of surgical gloves, such as dimensions, physical properties, or protein content, the results are typically determined by laboratory measurements and adherence to pre-defined thresholds within the specified ASTM standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. Such studies are relevant for devices that aid human readers in making diagnoses or interpretations (e.g., AI for radiology). Surgical gloves are a direct-use medical device; their effectiveness is measured by their inherent physical and biological properties.
6. Standalone Performance Study
Yes, a standalone performance study was done in the sense that the device's performance was evaluated against the specified standards independent of human intervention in its "reading" or "interpretation." The tests described (e.g., for dimensions, physical properties, freedom from holes, powder-free, protein content, biocompatibility) are all evaluations of the intrinsic characteristics of the glove itself.
7. Type of Ground Truth Used
The ground truth used is objective, measurable criteria defined by recognized industry standards and regulatory requirements. Specifically:
- ASTM Standards: ASTM D 3577 (for dimensions and physical properties), ASTM D 5151 (for freedom from holes), ASTM D 6124 (for powder-free residue).
- Protein Label Claim: A defined threshold of "50 micrograms or less of total water extractable protein per gram."
- Biocompatibility Testing: "Passes" criteria for Primary Skin Irritation in Rabbits and Guinea Pig Sensitization, which are also based on established testing protocols and acceptance thresholds.
8. Sample Size for the Training Set
Not applicable. The Encore Mark IV Powder Free Surgical Gloves are a physical medical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data used to train an algorithm. The manufacturing process of such gloves involves quality control and process validation, but this is distinct from training an AI model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, there is no "training set" for this device.
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DEC | 4 1998
Encore Mark IV Powder Free Surgical Gloves (Protein Labeling Claim) 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]
- [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 330-833-6213 Fax:
September 30, 1998
- Trade Name: Encore Mark IV Powder Free Surgical Gloves (Protein Labeling Claim) [3] Common Name: Surgical Gloves Classification Name: Surgeon's Glove
- [4] Encore Mark IV Powder Free Surgical Gloves (Protein Labeling Claim), meet all of the requirements of ASTM D 3577, Type 1.
- [૨] Encore Mark IV Powder Free Surgical Gloves (Protein Labeling Claim) meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves.
- [୧] Encore Mark IV Powder Free Surgical Gloves (Protein Labeling Claim) 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 (Protein Labeling Claim) 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 1 |
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Encore Mark IV Powder Free Surgical Gloves (Protein Labeling Claim) Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 330-833-2811 Telephone: 330-833-6213 Fax:
| Freedom from holes | Meets ASTM D 3577 |
|---|---|
| Meets ASTM D 5151 | |
| Powder-Free | Meets ASTM D 6124 |
| Meets described test in Attachment VI | Not more than 2 mg residue by mass. |
| Protein Label Claim | This latex glove contains 50 micrograms orless of total water extractable protein pergram. |
| Biocompatability | |
| Primary Skin Irritation in Rabbits | Passes |
The performance test data of the non clinical tests are the same as mentioned immediately above. [8]
Passes
- [9] Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process.
- It is concluded that Encore Mark IV Powder Free Surgical Gloves (Protein Labeling Claim) are as [10] safe, as 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.
Guinea Pig Sensitization
- [11] This summary will include any other information reasonably deemed necessary by The FDA.
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Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a symbol of three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 4 1998
Mr. James R. Chatterton Vice President Regulatory Affairs/Technical Ansell Perry, Incorporated 1875 Harsh Avenue S.E. Massillon, Ohio 44646
K983489 Re : Encore Mark IV Powder-Free Polymer Coated Trade Name: Latex Surgical Glove with Protein Content Labeling Claim (50 Micrograms or Less) Requlatory Class: I Product Code: KGO Dated: September 30, 1998 Received: October 5, 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 The general controls controls provisions of the Act. 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 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 requirements, as set forth in the Quality System Requlation (QS) for Medical General requlation (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 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
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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 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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.qov/cdrh/dsma/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
| Applicant: | Ansell Perry |
|---|---|
| 510(K) Number (if known): | K983489 * |
| Device Name: | Surgeons Glove, latex polymer coated, powder free with protein label claim (50 microGRAM OR LESS) |
| Indications For Use: |
A device made of natural 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 Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
OR
Prescription Use L `1 CFR 801.109
Over-The-Counter
er X
(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).