(68 days)
Safeskin Blue Nitrile Examination Glove
Not Found
No
The device is a medical glove, and the summary describes its intended use and performance based on material standards, not AI/ML capabilities. There are no mentions of AI, ML, image processing, or data sets for training/testing.
No
It is a protective device (glove) meant to prevent contamination, not to treat a medical condition or disease.
No
Explanation: The device is described as a medical glove intended to prevent contamination, not to diagnose a condition or disease.
No
The device description clearly states it is a "medical glove," which is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between healthcare personnel and the patient by being worn on the hands. This is a barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description reinforces the barrier function and the sterile nature for preventing contamination.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on glove performance standards (like ASTM) related to barrier integrity and physical properties, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This glove does not fit that description.
N/A
Intended Use / Indications for Use
A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
Safeskin Sterile Purple Nitrile Examination Gloves are sterile disposable devices intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare and similar personnel
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 Safeskin Sterile Purple Nitrile Examination Glove will meet all the current specifications for ASTM D 6319-99.
Safeskin Sterile Purple Nitrile Examination Gloves possess the following technological characteristics (as compared to ASTM or equivalent standards):
Dimensions: Meets ASTM D 6319-99
Physical Properties: Meets ASTM D 6319-99
Freedom from pinholes: Meets ASTM D 6319-99, Meets ASTM D 5151
Powder-Free: Meets ASTM D 6124, 2 mg/glove maximum
Biocompatibility:
Primary Skin Irritation in Rabbits: Passes
Guinea Pig Sensitization: Passes
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.
Safeskin Blue Nitrile Examination Glove
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
Safeskin Corporation
June 17, 1999
- 510(k) Summary of Safety and Effectiveness Information [1]
- [2] Safeskin Corporation 12671 High Bluff Drive San Diego, CA 92130
Telephone: 619-794-8111 Fax: 619-350-2382
Contact: Eugene V. Goorchenko Telephone: 619-509-7010 619-350-2382 Fax:
- [3] Trade Name: Safeskin Sterile Purple Nitrile Examination Gloves Common Name: Patient Examination Gloves Classification Name: Patient Examination Gloves
- [4] The predicate is a Safeskin Blue Nitrile Examination Glove which meets all of the requirements of ASTM D 6319-99, Standard Specification for Nitrile Examination Gloves for Medical Application.
- [5] The Safeskin Sterile Purple Nitrile Examination Glove will meet all the current specifications for ASTM D 6319-99.
- [୧] Safeskin Sterile Purple Nitrile Examination Gloves are sterile disposable devices intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient.
- [7] Safeskin Sterile Purple Nitrile Examination Gloves possess the following technological characteristics (as compared to ASTM or equivalent standards):
| Characteristics | Standards |
|---|---|
| Dimensions | Meets ASTM D 6319-99 |
| Physical Properties | Meets ASTM D 6319-99 |
| Freedom from pinholes | Meets ASTM D 6319-99 |
| Meets ASTM D 5151 | |
| Powder-Free | Meets ASTM D 6124 |
| 2 mg/glove maximum |
1
Biocompatability
| Primary Skin Irritation in Rabbits | Passes |
|---|---|
| Guinea Pig Sensitization | Passes |
- The performance test data that support a determination of substantial equivalence [8] are described above.
- Clinical data are not needed for surgical gloves. [9]
- It can be concluded that the Safeskin Sterile Purple Nitrile Examination Glove [10] will perform according to the glove performance standards referenced in Section 7 above and therefore will meet ASTM standards, FDA requirements, and the labeling claims for the product. Consequently, this device is substantially equivalent to currently marketed devices.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 25 1999
Mr. Eugene V. Goorchenko Director Of Requlatory Affairs Safeskin Corporation 12671 Hiqh Bluff Drive San Diego, California 92130
K992062 Re : Safeskin Sterile Purple Nitrile Examination Trade Name: Gloves (Powder Free) Requlatory Class: I LZA Product Code: Dated: June 17, 1999 Received: June 18, 1999
Dear Mr. Goorchenko:
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 Regulations, Title 21, Parts 800 to 895. ਜੋ 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 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
3
Page 2 - Mr. Goorchenko
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 or bubbeanced cquesults in a classification for your device and thus, permits your device to proceed to the market. endb/ Delmire your device for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in xitro diagnostic devices), please contact the Office of Compliance at Additionally, for questions on the promotion and (301) 594-4692. 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 Other general information on your responsibilities CFR 807.97). 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,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K92062
FDA 510(k), Premarket Notification
Safeskin Corporation
INDICATIONS FOR USE
Safeskin Corporation Applicant:
510(k) Number:
Sterile Purple Nitrile Patient Examination Glove Device Name:
Indications for Use:
A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Chun S. Lin
(Division Sign-Off) Division of Dental, Infection Co and Ganeral Hospital 510lk) Number
Over-The-Counter
10