(124 days)
A sterile disposable device intended for medical purpose that is worn on the examiners hand to prevent contamination between patient and examiner.
SYNSATION® Sterile Powder Free, Polyvinyl Chloride Medical Examination Gloves examination gloves are sterile disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
The SYNSATION® Sterile Powder Free, Polyvinyl Chloride Medical Examination Gloves undergo a performance study to demonstrate that they meet the acceptance criteria. The study ensures that the gloves conform to the specified standards and are safe and effective for their intended medical purposes.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 5250 | Meets ASTM D 5250 |
| Physical Properties | Meets ASTM D 5250 | Meets ASTM D 5250 |
| Freedom from holes | Meets ASTM D 5250 | Meets ASTM D 5250 |
| Meets ASTM D 5151 | Meets ASTM D 5151 | |
| Powder-Free | Not more than 2 mg residue by mass | Not more than 2 mg residue by mass |
| Meets ASTM D 6124 and ASTM D 5250 | Meets ASTM D 6124 and ASTM D 5250 | |
| Biocompatibility | ||
| Primary Skin Irritation in Rabbits | Passes | Passes |
| Guinea Pig Sensitization | Passes | Passes |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the specific sample size used for each test. However, the performance is reported against ASTM standards, which would imply that testing was conducted according to the sampling plans outlined within those standards. The data provenance is not specified in terms of country of origin, but the testing is non-clinical. The studies are assumed to be prospective, specifically designed to test the glove's performance against the established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not applicable. The device is a medical examination glove, and its performance is evaluated against established material and safety standards (ASTM standards and biocompatibility tests), not against expert clinical ground truth like in a diagnostic device. The "ground truth" here is the pass/fail criteria defined by the objective standards themselves.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as the evaluation involves objective measurements against predefined standards rather than subjective expert interpretation requiring adjudication.
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:
This information is not applicable. The device is a medical examination glove, which is a physical barrier device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable. The device is a medical examination glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance evaluation of these gloves is defined by:
- Established ASTM Standards: These are objective measurement criteria for physical properties (dimensions, tensile strength, elongation), freedom from holes, and powder residue.
- Biocompatibility Test Standards: These are established protocols for assessing primary skin irritation in rabbits and sensitization in guinea pigs, yielding objective pass/fail results.
8. The sample size for the training set:
This information is not applicable. The device is a physical medical glove and does not involve AI algorithms that require a "training set."
9. How the ground truth for the training set was established:
This information is not applicable, as there is no training set for this type of device.
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OCT 2 7 1999
SYNSATION® Sterile Powder Free, Polyvinyl Chloride Medical Examination Gloves Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 Telephone: 330-833-2811 330-833-6213 Fax:
Checklist Section 21.0
| [1] | 510 (k) Summary |
|---|---|
| ----- | ----------------- |
- (2) Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646
Telephone: 330-833-2811 Fax: 330-833-6213
Contact: James R. Chatterton Telephone: 330-833-2811 Fax: 330-833-6213
June 23, 1999
[3]
| Trade Name: | SYNSATION® Sterile Powder Free, Polyvinyl Chloride Medical Examination Gloves |
|---|---|
| Common Name: | Sterile Examination Gloves |
| Classification Name: | Patient Examination Glove, Sterile |
- [4] SYNSATION® Sterile Powder Free, Polyvinyl Chloride Medical Examination Gloves examination gloves, meet all of the requirements of ASTM D 5250, Poly (Vinyl Chloride) Gloves for Medical Application.
- [ર] SYNSATION® Sterile Powder Free, Polyvinyl Chloride Medical Examination Gloves examination gloves meet all the current specifications for ASTM D 5250, Poly (Vinyl Chloride) Gloves for Medical Application.
- (୧) SYNSATION® Sterile Powder Free, Polyvinyl Chloride Medical Examination Gloves examination gloves are sterile disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
- [7] SYNSATION® Sterile Powder Free, Polyvinyl Chloride Medical Examination Gloves examination gloves are summarized with the following technological characteristics compared to ASTM or equivalent standards.
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SYNSATION® Sterile Powder Free, Polyvinyl Chloride Medical Examination Gloves Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 Telephone: 330-833-2811 Fax: 330-833-6213
| Characteristics | Standard |
|---|---|
| Dimensions | Meets ASTM D 5250 |
| Physical Properties | Meets ASTM D 5250 |
| Freedom from holes | Meets ASTM D 5250Meets ASTM D 5151 |
| Powder-FreeMeets described test in Attachment VI | Not more than 2 mg residue by mass.Meets ASTM D 6124 and ASTM D 5250 |
| BiocompatabilityPrimary Skin Irritation in RabbitsGuinea Pig Sensitization | PassesPasses |
- [8] The performance test data of the non clinical tests are the same as mentioned immediately above.
- Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process. [9]
- [10] It is concluded that SYNSATION® Sterile Powder Free, Polyvinyl Chloride Medical Examination Gloves are as 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.
- 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 is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
0CT 2 7 1999
Mr. James R. Chatterton Vice President Regulatory Ansell Perry Ansell Healthcare Products, Incorporated 1875 Harsh Avenue S.E. Massillon, Ohio 44646
Re : K992156
Trade Name: SYNSATION® Sterile Powder Free, Polyvinyl Chloride Medical Examination Gloves Regulatory Class: I Product Code: LYZ Dated: September 17, 1999 Received: September 20, 1999
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 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 Regulations, 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in
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Page 2 - Mr. Chatterton
the Federal Register. Please note: this response to your che rederal neground submission does not affect any remarket notificacion babliable sections 531 through 542 of obligation you might have under becomic Product Radiation
the Act for devices under the Elections or regulations the Act for devices ander one Economics or regulations.
This letter will allow you to begin marketing your device as Inis recei will area your fromarket notification. The FDA described in your 510(x) prematice of your device to a legally
finding of substantial equivalence of your device for your finding of substancial equivalition in a classification for your marketed predicate device rebares in a sem-one of the market.
If you desire specific advice for your device on our labeling II you desire specific advice additionally 809.10 for in regulation (21 cm Fare oss are oss artact the Office of
vitro diagnostic devices), please contact the for quocti vitro diagnostic devices), preabscetionally, for questions on Compliance at (301) 394-4692. "Addresses ontact
the promotion and advertising of your device, please contact the promotion and advercibing or jean-4639. Also, please note the regulation entitled, "Misbranding by reference to the regulation entitled, "Misbranding »7 other general premarked notification - (2) circles under the Act may be information on your responsible mall Manufacturers Assistance obtained Trom the Division of Billing (801) or (301) 443-65597 or at at its toil-free number (000) obliga gov/cdrh/dsmamain.html".
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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INDICATIONS FOR USE
Applicant: _________________ Ansell Perry
K99256 510(K) Number (if known): __
Vinyl Patient Examination Glove, Sterile, Powder Free Device Name:
Indications For Use:
A sterile disposable device intended for medical purpose that is worn on the examiners hand to prevent contamination between patient and examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
3
Prescription Use P -- 21 CFR 801.109
OR
(Division Sign-Off)
and General Hospital D 510(k) Numbar
Division of Dental, Infection Control
Over-The-Counter
(Optional Form)
-The-Counter
(Optional Format 1-2-96)
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§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.