(57 days)
Not Found
Not Found
No
The summary describes sterile examination gloves, a simple barrier device, with no mention of AI, ML, image processing, or any computational capabilities.
No
The device, a sterile examination glove, is intended to prevent contamination between patient and examiner, which is a preventive measure rather than a therapeutic one. It does not treat or cure any medical condition.
No
The device is described as an examination glove intended to prevent contamination, not to diagnose a medical condition.
No
The device description clearly states it is a "disposable device" and "worn on the examiners hand," indicating a physical, hardware-based product (gloves).
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 samples taken from the body.
- Device Description: The description reinforces the intended use as a disposable device worn on the hand for contamination prevention.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health status. This device is a physical barrier for protection.
N/A
Intended Use / Indications for Use
A disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
Nitra-Touch™ Sterile examination gloves, meet all of the requirements of ASTM Standard D 6319 Nitrile Examination Gloves for Medical Application. Nitra-Touch™ Sterile examination gloves exceed the physical requirements of ASTM standard D 6319 Nitrile Examination Glove for Medical Application. Nitra-Touch™ Sterile 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 (medical purposes)
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. Biocompatibility tests performed: Primary Skin Irritation in Rabbits (Passes) and Guinea Pig Sensitization (Passes). Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process. It is concluded that Nitra-Touch™ Sterile examination gloves are as safe, as effective, and perform as well as or better than 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 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/0 description: The image shows the words "Ansell Perry" in a bold, sans-serif font. The word "Ansell" is in white on a black background, while the word "Perry" is in black on a white background. The two words are placed side by side, creating a contrast between the colors.
Nitra-Touch™ Sterile Powder-Free Nitrile Medical Examination Glove Ansell Perry
OCT 1 3 1999
1875 Harsh Avenue SE Massillon, Ohio 44646 330-833-2811 Telephone: Fax: 330-833-6213
Checklist Section 21.0
- 510 (k) Summary [1]
- [2] Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646
Telephone: 330-833-2811 Fax: 330-833-6213
James R. Chatterton Contact: 8/11/99 Date:
- Nitra-Touch™ Sterile [3] Trade Name: Exam Gloves Common Name: Patient Examination Glove Classification Name:
- Nitra-Touch™ Sterile examination gloves, meet all of the requirements of ASTM Standard D 6319 . [4] Nitrile Examination Gloves for Medical Application.
- Nitra-Touch™ Sterile examination gloves exceed the physical requirements of ASTM standard D [૨] 6319 Nitrile Examination Glove for Medical Application.
- Nitra-Touch™ Sterile examination gloves are disposable device intended for medical purposes that [୧] is worn on the examiners hand to prevent contamination between patient and examiner.
- [7] Nitra-Touch™ Sterile examination gloves are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| Characteristics | Standard |
|---|---|
| Dimensions | Meets ASTM D 6319 |
| Physical Properties | |
| Tensile Strength, minimum | Meets ASTM D 6319 |
| 14 Mpa | |
| Freedom from holes | Meets ASTM D 6319 |
| Meets ASTM D 5151 | |
| Powder-Free | Not more than 2 mg residue by mass |
| Meets ASTM D 6124 |
Ansell Healthcare Products Inc. • 1875 Harsh Ave. S.E. • Massillon, Ohio 44646 • U.S.A. http://www.ansell.com Telephone: 330-833-2811 · Toll Free: 800-321-9752 (USA only) · Fax: 330-833-5991
1
Nitra-Touch™ Sterile Powder-Free Nitrile Medical Examination Glove Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 Telephone: 330-833-2811 330-833-6213 Fax:
Biocompatability Primary Skin İrritation in Rabbits Guinea Pig Sensitization
Passes 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. [9]
- It is concluded that Nitra-Touch™ Sterile examination gloves are as safe, as effective, and perform [10] as well as or better than 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
Image /page/2/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol in the center. The symbol appears to be a stylized representation of a bird or a human figure, with flowing lines suggesting movement or growth.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 3 1999
Mr. James R. Chatterton Vice President Regulatory Affairs/Technical Ansell Perry Ansell Healthcare Products Inc. 1875 Harsh Avenue S.E. Massillon, Ohio 44646
K992768 Re : Trade Name: Nitra-Touch™ Sterile Powder-Free Nitrile Medical Examination Gloves Regulatory Class: I Product Code: LZA August 11, 1999 Dated: August 17, 1999 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 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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
3
Page 2 - Mr. Chatterton
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 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) 594-4692. 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) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Susan Runno
t
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
~ ^ Indications for Use Statement:
INDICATIONS FOR USE
| Applicant: | Ansell Perry |
|---|---|
| 510(K) Number (if known): | K992768 * |
| Device Name: | Nitra-Touch Patient Examination Glove, Sterile, Nitrile, Green Color, Sterile, Powder Free |
| Indications For Use: |
A disposable device intended for medical purposes 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)
Olin S. Lim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number
es ... .ption Use r 21 CFR 801.109 OR
Over-The-Counter
ter
...
(Optional Format 1-2-96)