(47 days)
Not Found
Not Found
No
The summary describes a simple disposable barrier device and contains no mention of AI, ML, image processing, or data analysis.
No
Explanation: The device is intended to prevent contamination between the patient and examiner, functioning as a barrier rather than for treatment or diagnosis of a disease or condition.
No
The device's intended use is to prevent contamination between patient and examiner, which is a barrier function, not a diagnostic one. It doesn't gather or analyze information about a patient's health condition.
No
The device is described as a "disposable device" that is "worn on the examiners hand," indicating a physical, hardware component. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the hand. This is a physical barrier function, not a diagnostic test performed on biological samples in vitro (outside the body).
- Device Description: While "Not Found," the intended use clearly describes a physical barrier device.
- No mention of biological samples: There is no indication that this device interacts with or analyzes biological samples (blood, urine, tissue, etc.) which is a core characteristic of IVDs.
- No mention of diagnostic purpose: The purpose is preventative (preventing contamination), not diagnostic (identifying a disease or condition).
This device appears to be a medical glove, which is a Class I or Class II medical device depending on its intended use (e.g., examination or surgical).
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
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized representation of an eagle with three wavy lines extending from its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 4 1997
Mr. James R. Chatterton Vice President Regulatory Affairs/Technical Ansell Perry Incorporated _ 1875 Harsh Avenue, S.E. Massillon, Ohio 44646-9987
K971424 Re : Dermaclean X-AM™ Powder-Free Latex, Trade Name: Examination Gloves with Protein Labeling Claim Requlatory Class: T Product Code: LYY Dated: April 16, 1997 Received: April 18, 1997
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 The general controls provisions of the Act 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. ಕಿ 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 requlation may result in regulatory 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 not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Mr. Chatterton
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
premarket notification" (21 CFR 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) 63 -2041 or at (301) 443-6597.
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
2
INDICATIONS FOR USE
| Applicant: | Ansell Perry Inc. |
|---|---|
| 510(K) Number (if known): | K971424 * |
| Device Name: | Patient Examination Glove, Powder Free with Protein Label Claim |
Indications For Use:
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)
| S. Lin | |
|---|---|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K971424 |
| Prescription Use 1 CFR 801.109 | |
|---|---|
| -------------------------------- | -- |
OR
| Over-The-Counter | X |
|---|---|
| ------------------ | --- |
(Optional Format 1-2-96)
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