(38 days)
A disposable device intended for medical purpose that is worn on the examiners hand to prevent contamination between patient and examiner.
DermaClean Sterile (Protein Labeling Claim) examination gloves, meet all of the requirements of ASTM D 3578. DermaClean Sterile (Protein Labeling Claim) examination gloves meet all the current specifications for ASTM D 3578 Rubber Examination Gloves. DermaClean Sterile (Protein Labeling Claim) examination gloves are disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 3578 | Meets ASTM D 3578 |
| Physical Properties | Meets ASTM D 3578 | Meets ASTM D 3578 |
| Freedom from holes | Meets ASTM D 3578 & ASTM D 5151 | Meets ASTM D 3578 & ASTM D 5151 |
| Powder-Free | Not more than 2 mg residue by mass | Not more than 2 mg residue by mass |
| Protein Label Claim | 50 micrograms or less of total water extractable protein per gram | 50 micrograms or less 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 document does not explicitly state the sample sizes used for each specific test (e.g., freedom from holes, physical properties). However, it implies that the tests were conducted according to the respective ASTM standards, which would dictate appropriate sample sizes for each test.
The data provenance is not explicitly stated in terms of country of origin but is implicitly from Ansell Perry Inc. in Massillon, Ohio, USA. The studies are retrospective as they are internal validation tests against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The ground truth for the performance of the gloves is established by the well-defined and objective criteria set forth in the ASTM standards (ASTM D 3578, ASTM D 5151) and the documented residue limits and protein content limits. These are not subject to expert interpretation for ground truth establishment in the same way as, for example, medical image diagnosis.
4. Adjudication Method for the Test Set
This information is not applicable. The performance is assessed against objective, measurable standards as outlined in the ASTM specifications and internal test methods. There is no need for expert adjudication in the traditional sense for these types of physical and chemical tests.
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
No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for AI-powered diagnostic tools where human interpretation is involved. This device is a medical glove, and its performance is assessed through physical and chemical properties, not by human interpretation that could be augmented by AI.
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 physical product (medical glove), not an algorithm or AI system. Its performance is inherent to the product itself, not to a computational model.
7. The type of ground truth used
The ground truth used for these tests is based on objective, measurable criteria defined by established industry standards (ASTM D 3578, ASTM D 5151) and specific numerical thresholds (e.g., 2 mg residue, 50 micrograms protein). These standards provide the definitive "ground truth" for what constitutes acceptable performance for a medical examination glove.
8. The sample size for the training set
This information is not applicable. The device is a manufactured product, and its performance is determined by its design, materials, and manufacturing process, not trained using a dataset in the way an AI model is. There is no concept of a "training set" for physical product testing in this context.
9. How the ground truth for the training set was established
This information is not applicable, as there is no "training set" for this product. The ground truth for acceptable performance is established by the aforementioned ASTM standards and specific limits.
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DEC 18 1997
DermaClean Sterile (Protein Labeling Claim) Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 330-833-2811 Telephone: 330-833-6213 Fax:
Checklist Section 21.0
- [1] 510 (k) Summary
- [2] Ansell Perry Inc. 1875 Harsh Avenue SE Massillon, Ohio 44646
330-833-2811 Telephone: Fax: 330-833-6213
Contact: James R. Chatterton Telephone: 330-833-2811 330-833-6213 Fax:
October 28, 1997
·
- DermaClean Sterile (Protein Labeling Claim) Trade Name: [3] Examination Gloves Common Name: Classification Name: Patient Examination Glove
- DermaClean Sterile (Protein Labeling Claim) examination gloves, meet all of the requirements of [4] ASTM D 3578.
- DermaClean Sterile (Protein Labeling Claim) examination gloves meet all the current [ર] specifications for ASTM D 3578 Rubber Examination Gloves.
- DermaClean Sterile (Protein Labeling Claim) examination gloves are disposable device intended [6] for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
- DermaClean Sterile (Protein Labeling Claim) examination gloves are summarized with the [7] following technological characteristics compared to ASTM or equivalent standards.
| Characteristics | Standard |
|---|---|
| Dimensions | Meets ASTM D 3578 |
| Physical Properties | Meets ASTM D 3578 |
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| DermaClean Sterile (Protein Labeling Claim)Ansell Perry1875 Harsh Avenue SEMassillon, Ohio 44646Telephone: 330-833-2811Fax: 330-833-6213 | |
|---|---|
| Freedom from holes | Meets ASTM D 3578Meets ASTM D 5151 |
| Powder-FreeMeets 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 |
| Guinea Pig Sensitization | 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. િંત્ર
- It is concluded that DermaClean Sterile (Protein Labeling Claim) examination gloves are as safe, [10] 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized lines forming its body and wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 18 1997
Mr. James R. Chatterton Vice President Regulatory Affairs/Technical Ansell Perry Incorporated 1875 Harsh Avenue, S.E. Massillon, Ohio 44646-7199
K974218 Re : Dermaclean Sterile Latex Examination Gloves Trade Name: with Protein Label Claim (50 micrograms or less of total water extractables protein per gram.) Regulatory Class: I Product Code: LYY October 28, 1997 Dated: November 10, 1997 Received:
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 aqainst 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. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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
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Paqe 2 - Mr. Chatterton
not affect any obligation you might have under sections 531 through 542 of 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) 594-4618. 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 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
Diredtor 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
Ansell Perry Inc. Applicant:
510(K) Number (if known): _ K974218
Latex Patient Examination Glove Sterile, Powder Free with Protein Label Claim (50 Device Name: micrograms or less of total water extractables protein per gram.
Indications For Usc.
A 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)
Chin S. Lin
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices,
510(k) Number K974218
Prescription Use
Per 21 CFR 801.109
OR
Over-The-Counter V
(Optional Format 1-2-96)
3
ANSWELL PARKS
§ 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.