(56 days)
Not Found
No
The summary describes a surgical glove and makes no mention of AI or ML technology.
No
The device is a surgeon's glove, which is used to protect a surgical wound from contamination and the user from infection, rather than to treat a specific disease or condition.
No
The device is described as a "powder-free sterile surgeon's glove" intended to protect a surgical wound from contamination, not to diagnose any condition.
No
The device description clearly states it is a physical glove made of natural rubber latex, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The description clearly states the device is a "powder-free sterile surgeon's glove" intended to be worn by operating room personnel to protect a surgical wound from contamination. This is a physical barrier device used during a medical procedure, not a device used to analyze specimens outside the body.
- Intended Use: The intended use is for protection during surgery, not for diagnostic testing of biological samples.
The information provided about the device's material, manufacturing, and performance testing (meeting ASTM standards) further confirms its nature as a medical device used for protection and barrier purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
A powder-free sterile surgeon's glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Product codes
KGO
Device Description
The proposed device is a disposable device intended for over the counter use and is provided powder-free and sterile. It is made with natural rubber latex and is tan in color. The glove is manufactured using molds that feature independent thumb and tapered mechanically locking cuffs to help reduce cuff roll down.
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
Non-clinical data demonstrates that ProtexisTM Latex Basic, Sterile Latex Powder-Free Surgical Gloves with Protein Content Label Claim (50 micrograms or less) meet the technological characteristics of ASTM D3577 standard, and are as safe, as effective, and performed as well as the legally marketed devices identified in this summary.
Key Metrics
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
MAY 2 3 2012
Image /page/0/Picture/2 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic above the company name. The graphic appears to be three curved lines converging at a point, possibly representing birds in flight or a similar abstract design.
Page _1_of
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
PROTEXISTM LATEX BASIC, STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABEL CLAIM OF 50µg/dm2 OR LESS (TAN) (A summary of safety and effectiveness information in accordance with the requirements of 21 CFR 807.92)
Cardinal Health Applicant: 1430 Waukegan Road McGaw Park, IL 60085 Establishment Registration 1423537 Number: Regulatory Affairs Contact: Tatyana Bogdan, RAC Telephone: 847-887-2325 847-887-2717 Fax: tatyana.bogdan-curvin@cardinalhealth.com E-mail:
Summary Prepared: May 9, 2012
Protexis Tid Latex Basic, Sterile Latex Powder-Free Surgical Glove with Trade Name: Protein Content Label Claim of 50ug/dm2 or less (Tan) Surgeon's Gloves Common Name:
Classification Name: Surgeon's Gloves
Classification Panel: General and Plastic Surgery
21 CFR 878.4460 Regulation:
Product Code(s): KGO
Legally marketed device(s)
to which equivalence Ultrafree Sterile Powder-Free Latex/ Surgical Gloves (510(k) K964474, product code KGO)
Reason for 510(k) Submission:
New device
Device Description: The proposed device is a disposable device intended for over the counter use and is provided powder-free and sterile. It is made with natural rubber latex and is tan in color. The glove is manufactured using molds that feature independent thumb and tapered mechanically locking cuffs to help reduce cuff roll down.
This powder-free surgeon's glove is a disposable device made of natural Intended Use: rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
10
1
K120934
・
·
| Characteristic | New Device | Predicate device | |
|---|---|---|---|
| Material | |||
| Composition | ProtexisTM Latex Basic, Sterile | ||
| Latex Powder-Free Surgical Gloves | |||
| with Protein Content Label Claim | |||
| of 50 $\mu$ g/dm2 or less (Tan) | Ultrafree Sterile Latex Powder-Free | ||
| Surgical Glove (K964474) | |||
| Design | Single Use | ||
| Sterile | |||
| Powder-free | |||
| Hand Specific | |||
| Independent Thumb | |||
| Beaded Cuff | |||
| Lubricated | Single Use | ||
| Sterile | |||
| Powder-free | |||
| Hand Specific | |||
| Independent Thumb | |||
| Beaded Cuff | |||
| Lubricated | |||
| Intended Use/ | |||
| Indications for Use | Powder-Free Surgeon's Glove | Powder-Free Surgeon's Glove | |
| Dimensions & | |||
| Physical Properties | Meets ASTM D3577 | Meets ASTM D3577 | |
| Freedom from | |||
| Holes | AQL meets 21CFR 800.20 & | ||
| ASTM D3577 requirements | AQL meets 21CFR 800.20 & ASTM | ||
| D3577 requirements | |||
| Powder Residual | Meets requirements of $\le$ 2.0 | ||
| mg/glove for Powder-Free | |||
| designation per ASTM D3577 | Meets requirements of $\le$ 2.0 mg/glove | ||
| for Powder-Free designation per | |||
| ASTM D3577 | |||
| Protein Contents | Contains less than 50 $\mu$ g/dm2 of | ||
| total water extractable protein per | |||
| glove as tested per ASTM D5712 | N/A | ||
| Powder Residual | ASTM D3577 tested | ||
| using ASTM standard | |||
| D6124 | Gloves meet powder level requirements for | ||
| “Powder-Free” designation per ASTM | |||
| D3577. Results generated values |