(38 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of examination gloves, with no mention of AI or ML technologies.
No.
The device, "DermaClean Sterile examination gloves," is intended to prevent contamination between patient and examiner, acting as a barrier. It does not directly treat or alleviate a disease, injury, or medical condition.
No
Explanation: The device, DermaClean Sterile examination gloves, is described as a disposable device worn on the examiner's hand to prevent contamination. Its intended use and description do not mention any function related to diagnosing diseases, conditions, or injuries.
No
The device is described as a disposable glove worn on the hand, which is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "worn on the examiners hand to prevent contamination between patient and examiner." This describes a barrier device used for infection control, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical properties and standards met by examination gloves (ASTM D 3578), which are barrier devices.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, assays, or any other components typically associated with in vitro diagnostics.
Therefore, this device falls under the category of a medical device used for infection control, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A disposable device intended for medical purpose that is worn on the examiners hand to prevent contamination between patient and examiner.
Product codes
LYY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. It is concluded that DermaClean Sterile (Protein Labeling Claim) 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not more than 2 mg residue by mass for Powder-Free test.
This latex glove contains 50 micrograms or less of total water extractable protein per gram.
Primary Skin Irritation in Rabbits: Passes
Guinea Pig Sensitization: Passes
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 |
1
| DermaClean Sterile (Protein Labeling Claim)
Ansell Perry
1875 Harsh Avenue SE
Massillon, Ohio 44646
Telephone: 330-833-2811
| Fax: 330-833-6213 | |
|---|---|
| Freedom from holes | Meets ASTM D 3578 |
| Meets ASTM D 5151 | |
| Powder-Free | |
| Meets described test in Attachment VI | Not more than 2 mg residue by mass. |
| Protein Label Claim | This latex glove contains 50 micrograms or |
| less of total water extractable protein per | |
| gram. | |
| 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]
2
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
3
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
4
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)
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ANSWELL PARKS