(28 days)
Not Found
No
The device description and performance studies focus on the physical and material properties of a surgical glove, with no mention of AI or ML.
No
Explanation: The device is a surgeon's glove, intended to protect from contamination, not to treat or diagnose a disease or condition.
No
The device is a surgeon's glove, intended to protect a surgical wound from contamination, not to diagnose a condition.
No
The device is a physical surgical glove made of natural rubber latex, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be worn by operating room personnel to protect a surgical wound from contamination. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description focuses on the physical characteristics of the glove (material, color, features) and its intended use as a barrier.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or condition.
- Performance Studies: The performance studies focus on the physical properties of the glove (dimensions, strength, freedom from holes, powder residual, protein content) and biocompatibility, which are relevant to its function as a protective barrier, not a diagnostic tool.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This surgical glove does not fit that description.
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 (comma separated list FDA assigned to the subject device)
KGO
Device Description
The proposed device is a disposable device intended for over the counter use and is provided powder-free and sterile. The glove is made with natural rubber latex and is cream 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE*
Performance Test Summary-New Device
Characteristic: Biocompatibility: Primary Skin Irritation
Standard/Test/FDA Guidance: ISO 10993-10
Results Summary: Meet requirements
Characteristic: Biocompatibility: Guinea Pig Maximization
Standard/Test/FDA Guidance: ISO 10993-10
Results Summary: Meet requirements
Characteristic: Physical Characteristics: Dimensions
Standard/Test/FDA Guidance: ASTM D3577
Results Summary: Meet requirements
Characteristic: Physical Characteristics: Physical Properties
Standard/Test/FDA Guidance: ASTM D3577
Results Summary: Meet requirements for rubber surgical gloves
Characteristic: Physical Characteristics: Freedom from Holes
Standard/Test/FDA Guidance: 21 CFR 800.20 & ASTM D3577
Results Summary: Tested in accordance with ASTM D5151 with acceptable results
Characteristic: Physical Characteristics: Powder Residual
Standard/Test/FDA Guidance: ASTM D3577 tested using ASTM standard D6124
Results Summary: Gloves meet powder level requirements for "Powder-Free" designation per ASTM D3577. Results generated values
§ 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
K121897
JUL 2 7 2012
Cardinal Health
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
PROTEXIS™ LATEX BASIC, STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABEL CLAIM OF 50µg/dm2 OR LESS (CREAM)
(A summary of safety and effectiveness information in accordance with the requirements of 21 CFR 807.92)
Applicant:
Cardinal Health 1430 Waukegan Road McGaw Park, IL 60085
| Establishment Registration | |
|---|---|
| Number: | 1423537 |
| Regulatory Affairs | |
| Contact: | Tatyana Bogdan, RAC |
| Telephone: | 847-887-2325 |
| Fax: | 847-887-2717 |
| E-mail: | tatyana.bogdan-curvin@cardinalhealth.com |
Summary Prepared: June 14, 2012
Protexis™ Latex Basic, Sterile Latex Powder-Free Surgical Glove with Trade Name: Protein Content Label Claim of 50ug/dm2 or less (Cream)
Common Name: Surgeon's Gloves
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 Protexis™ Latex Basic, Sterile Latex Powder-Free Surgical Gloves with Protein Content Label Claim of 50ug/dm2 or less (Tan) (510(k) K120934, product code KGO)
Reason for 510(k) Submission:
Device modification to remove colorant from glove formulation.
Device Description:
Device Description: The proposed device is a disposable device intended for over the counter use and is provided powder-free and sterile. The glove is made with natural rubber latex and is cream in color. The glove is manufactured using molds that feature independent thumb and tapered mechanically locking cuffs to help reduce cuff roll down.
10
1
Intended Use:
.
This powder-free surgeon's glove is a disposable device made of natural This powater 1100 be worn by operating room personnel to protect a surgical wound from contamination.
| Summary of the technological characteristics of the device compared to the predicate device | ||
|---|---|---|
| Characteristic | Modified Device | Original device (Predicate device cleared under K120934) |
| Material Composition | Sterile Latex Powder-Free Surgical Gloves with Protein Content Label | |
| Claim of 50 µg/dm² or less (Cream) | Sterile Latex Powder-Free Surgical Gloves with Protein Content Label | |
| Claim of 50 µg/dm² or less (Tan) | ||
| Material Composition | Natural Rubber Latex | Natural Rubber Latex |
| 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 ≤2.0 mg/glove for Powder-Free designation per ASTM D3577 | Meets requirements of ≤2.0 mg/glove for Powder-Free designation per ASTM D3577 |
| Protein Contents | Contains less than 50 µg/dm² of total water extractable protein per glove as tested per ASTM D5712 | Contains less than 50 µg/dm² of total water extractable protein per glove as tested per ASTM D5712 |
| PERFORMANCE DATA | ||
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF | ||
| SUBSTANTIAL EQUIVALENCE* | ||
| Performance Test Summary-New Device | ||
| Characteristic | Standard/Test/FDA Guidance | Results Summary |
| Biocompatibility: | ||
| Primary Skin Irritation | ISO 10993-10 | Meet requirements |
| Guinea Pig Maximization | ISO 10993-10 | Meet requirements |
| Physical Characteristics: |
2
| Dimensions | ASTM D3577 | Meet requirements | |||||
|---|---|---|---|---|---|---|---|
| Physical Properties | ASTM D3577 | Meet requirements for rubber surgical gloves | |||||
| Freedom from Holes | 21 CFR 800.20 & | Tested in accordance with ASTM D5151 with | |||||
| ASTM D3577 | acceptable results | ||||||
| Powder Residual | ASTM D3577 tested | Gloves meet powder level requirements for | |||||
| using ASTM standard | "Powder-Free" designation per ASTM | ||||||
| D6124 | D3577. Results generated values 18 9 / Page of |
Cardinal Health, Inc. Premarket Notification Submission - Special 510(k)
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