(147 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a medical glove, with no mention of AI or ML technology.
No.
The device description indicates its purpose is to prevent contamination, which is a protective function rather than a therapeutic one (treating or alleviating a medical condition).
No
The device, an examination glove, is intended for preventing contamination, not for diagnosing any medical condition or gathering diagnostic information.
No
The device is a physical examination glove made of synthetic material, not software. The description focuses on material properties and physical performance tests.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the glove is "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description focuses on the material and physical properties of the glove, again emphasizing its barrier function.
- 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 mentioned are biocompatibility tests, which are relevant for devices that come into contact with the body, but not indicative of an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not fit that description.
N/A
Intended Use / Indications for Use
The 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.
Product codes
LYY
Device Description
Tactyl's powder free examination gloves are manufactured using TACTYLON™. TACTYLON™ gloves are made of a synthetic material that mimics latex but contain no natural rubber latex. It is also powder free for those users who will benefit from such requirements. The glove meets the physical property requirements of ASTM 3578-91 Rubber Examination Gloves. The 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
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)
Various biocompatibility tests were successfully performed. Delayed Contact Sensitization Study (Repeated Patch Method) was performed in the Guinea Pig and showed no evidence of causing delayed dermal sensitization in the guinea pig. Another test conducted was the Primary Skin Irritation Test (FHSA) in the New Zealand white albino rabbit The test demonstrated the glove not to be a primary skin irritant.
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.
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
TACTYL TECHNOLOGIES, INC.
2595 COMMERCE WAY
VISTA, CA 92083
TEL. (619) 598-2233
FAX (619) 598-1012
ICATF
Powder Free Examination Glove 510(k) Summary DUPL
A. SUBSTANTIAL EQUIVALENCE:
Substantial equivalence is shown by comparing the subject device, a powderfree examination glove, to a previously marketed device with 510(k) clearance. The following information is submitted in compliance of a 510(k) summary as required by 21 CFR 807.92
| 1. Submitted by:
(& Manufactured by) | Tactyl Technologies, Inc.
2595 Commerce Way
Vista, CA 92083 | APR 25 1996 |
|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|-------------|
| Date Prepared: | 12 April, 1996 | |
| 2. Facility Registration:
Classification Name:
Common Name:
Proprietary Name: | 2027921
80LYY
Powder Free Examination Glove
TACTYLON™ Powder Free Examination Glove | |
| 3. Substantially Equivalent
Device: | TACTYLON™ Examination Glove [510(k) K905109] | |
| 4. Marketed by: | Tactyl Technologies, Inc.
2595 Commerce Way
Vista, CA 92083 | |
| | Other firms may market the product under a
private label agreement and sell under their
own brand, one such firm is: | |
| | SmartCare
3400 East McDowell
Phoenix, AZ 85008-7899 | |
| 5. Device Class: | I | |
| 6. Contact Person: | Jorge Haider
Director of Regulatory Affairs & Quality Assurance | |
1
B. DEVICE DESCRIPTION:
Tactyl's powder free examination gloves are manufactured using TACTYLON™ . TACTYLON™ gloves are made of a synthetic material that mimics latex but contain no natural rubber latex. It is also powder free for those users who will benefit from such requirements. The glove meets the physical property requirements of ASTM 3578-91 Rubber Examination Gloves. The 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.
C. COMPARISON TO TACTYLON™ EXAMINATION GLOVE:
The powder free glove has dramatically reduced powder levels from its equivalent, TACTYLON™ examination glove. The powder free glove has an added coat of material that is treated to provide donning characteristics without having to use corn starch. The physical properties of the glove remain well within the requirements established by ASTM 3578 and remain comparable to TACTYLON™ examination gloves.
The product is tested to and has passed the FDA test for water tightness using 1000 ml of water as called for in 21 CFR 800. This test requires gloves to be mounted on a test fixture and 1000 ml of water must be added. Leakage is defined as water escaping through the glove in any area of the glove, except the top 1½ inches that is attached to the mounting fixture. Any leakage occurring after two minutes is considered a failure. Gloves must pass an Acceptable Quality Level (AQL) of 4.0 as defined in 21 CFR 800.
D. CLINICAL AND NON-CLINICAL TESTING AND THEIR CONCLUSIONS:
Various biocompatibility tests were successfully performed. Delayed Contact Sensitization Study (Repeated Patch Method) was performed in the Guinea Pig and showed no evidence of causing delayed dermal sensitization in the guinea pig. Another test conducted was the Primary Skin Irritation Test (FHSA) in the New Zealand white albino rabbit The test demonstrated the glove not to be a primary skin irritant.
Jorge Haider
Jorge Haider
Date
12 April 96
Director of Regulatory Affairs and Quality Assurance