(140 days)
No
The summary describes a surgical glove and its physical properties and testing, with no mention of AI or ML.
No.
The surgical glove is intended to protect a surgical wound from contamination, which is a barrier function, not a direct therapeutic action to treat or cure a disease or condition.
No
The device description clearly states its purpose is to protect a surgical wound from contamination, and it is intended to be worn, not to diagnose. The testing described focuses on glove integrity and biocompatibility, not on diagnostic capabilities.
No
The device description clearly indicates it is a physical surgical glove made of synthetic material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect a surgical wound from contamination by being worn by operating room personnel. This is a barrier function for infection control, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the material and physical properties of the glove, designed for its barrier function and comfort.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or provide information about a patient's health status or disease.
- Testing: The testing described (water tightness, biocompatibility) relates to the glove's physical integrity and safety for contact with skin, not its ability to perform a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This surgical glove does not fit that definition.
N/A
Intended Use / Indications for Use
The surgical glove is intended to be worn by operating room personnel to protect a surgical wound from contamination.
Product codes
79KGO
Device Description
Tactyl's powder free surgical 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 3577-91 Rubber Surgical Gloves, Type II, compounded from a rubber cement or from synthetic rubber latex. The surgical glove is intended to be worn by operating room personnel to protect a surgical wound from contamination.
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
operating room 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)
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 quinea 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).
0
APR-10-96 WED 7:20 AM TACTYL. TECHNOLOGIE » FAX NO. 6195981012
195981012 P. 6
K955419
K955419
TACTYL TECHNOLOGIES, INC.
APR 1 5 1996
2595 COMMERCE WAY VISTA, CA 92083 TEL. (619) 598-2233 FAX (619) 598-1012
Powder Free Sterile Surgical Glove 510(k) Summary
A, SUBSTANTIAL EQUIVALENCE:
Substantial equivalence is shown by comparing the subject device, a powderfree surgical 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 |
|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Date Prepared: | 8 April, 1996 |
| 2. Facility Registration
Classification Name:
Common Name:
Proprietary Name: | 2027921
79KGO
Powder Free Surgical Glove
TACTYLON™ Powder Free Surgeons Glove |
| 3. Substantially Equivalent
Device: | TACTYLON ™ Surgical Glove [510(k) K902831]
TACTYLON™ Powder Free Surgical Glove
[510(k) K950185] |
| 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 |
SmartCare 3400 East McDowell Phoenix, AZ 85008-7899
own brand, one such firm is:
1
B. DEVICE DESCRIPTION:
Tactyl's powder free surgical 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 3577-91 Rubber Surgical Gloves, Type II, compounded from a rubber cement or from synthetic rubber latex. The surgical glove is intended to be worn by operating room personnel to protect a surgical wound from contamination.
C. COMPARISON TO TACTYLON™ SURGICAL GLOVE:
The powder free glove has dramatically reduced powder levels from its equivalent, TACTYLON™ surgical 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 3577 and remain comparable to TACTYLON™ surgical 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 2.5% 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 quinea 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 Haid 10 April 96
forge Maider firector of Regulatory Affairs and Quality Assurance
Date