(82 days)
No
The 510(k) summary describes a surgical glove and does not mention any AI or ML components or functionalities.
No
The document describes a surgeon's glove, which is a protective barrier device, not a device intended to treat or cure a disease or condition directly.
No
The device is a surgical glove, intended to protect a surgical wound from contamination, not to diagnose a condition.
No
The device is a physical surgical glove made of synthetic rubber, not software.
Based on the provided text, 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, not a diagnostic test performed on a sample from the human body.
- Device Description: The description focuses on the material (synthetic rubber), manufacturing process, and features of a glove. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
Therefore, this device is a surgical glove, which is a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This powder-free surgeon's glove is a disposable device made of synthetic 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 sterile. It is not made with natural rubber latex. Instead, it is formulated from polyisoprene, which is synthetic rubber latex. This sterile polyisoprene powder-free surgical glove is manufactured using exact same material used in the currently cleared device, Esteem Blue glove (K042574) that has been legally marketed by Cardinal Health for many years. The glove is coated with emollient coating containing Glycerol, Gluconolactone, D-Sorbitol and Provitamin-B. The glove is manufactured using molds that feature anti-slip finish, independent thumb, and tapered mechanically locking cuffs to help reduce cuff roll down. It is offered powder-free and sterile.
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
- Biocompatibility:
- Primary Skin Irritation (ISO 10993-10): Gloves are non-irritating.
- Guinea Pig Maximization (ISO 10993-10): Gloves do not display any potential for sensitization.
- Physical Characteristics:
- Dimensions (ASTM D3577): Meet requirements
- Physical Properties (ASTM D3577): Meet requirements for rubber surgical gloves
- Freedom from Holes (21 CFR 800.20 & ASTM D3577): Tested in accordance with ASTM D5151 with acceptable results
- Powder Residual (ASTM D3577 tested using ASTM standard D6124): 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
SEP 2 1 2011
Image /page/0/Picture/2 description: The image shows the logo for Cardinal Health. The logo consists of a stylized bird-like graphic above the company name. The text "CardinalHealth" is written in a bold, sans-serif font, with the first word in red and the second word in black.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS for STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA® COATING
(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
| 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, 2011
| Trade Name: | Sterile Polyisoprene Powder-Free Blue Surgical Gloves with Neu-Thera Coating |
|---|---|
| Common Name: | Surgeon's Gloves |
| Classification Name: | Surgeon's Gloves |
| Classification Panel: | General and Plastic Surgery |
| Regulation: | 21 CFR 878.4460 |
| Product Code(s): | KGO |
| Legally marketed device(s) to which equivalence is claimed: | Esteem® Blue Sterile Polyisoprene Powder-Free Surgical Gloves with Neu-Thera Coating (containing Chitosan, Provitamin B5, Gluconolactone and Glycerol) cleared under 510(k) K042574 (product code KGO) |
| Reason for 510(k) Submission: | Modification of a legally marketed device |
Device Description: The proposed device is a disposable device intended for over the counter use and is provided sterile. It is not made with natural rubber latex. Instead, it is formulated from polyisoprene, which is synthetic rubber latex. This sterile polyisoprene powder-free surgical glove is manufactured using exact same material used in the currently cleared device, Esteem Blue glove (K042574) that has been legally marketed by Cardinal Health for many years. The glove is coated with emollient coating containing Glycerol, Gluconolactone, D-Sorbitol and
1
Provitamin-B. The glove is manufactured using molds that feature anti-slip finish, independent thumb, and tapered mechanically locking cuffs to help reduce cuff roll down. It is offered powder-free and sterile.
Intended Use:
This powder-free surgeon's glove is a disposable device made of synthetic rubber intended to 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 (Predicate) |
| Material | ||
| Composition | Synthetic Rubber Latex - | |
| Polyisoprene | Synthetic Rubber Latex - | |
| Polyisoprene | ||
| Sterile Polyisoprene Powder-Free | ||
| Blue Surgical Gloves with Neu- | ||
| Thera Coating | Esteem Blue Sterile Polyisoprene | |
| Powder-Free Surgical Glove with | ||
| Neu-Thera Coating (K042574) | ||
| 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 | ||
| Coating | ||
| Contents | Provitamin B, Gluconolactone, D- | |
| Sorbitol and Glycerol | Chitosan, Provitamin B, | |
| Gluconolactone, D-Sorbitol and | ||
| Glycerol | ||
| 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 |
2
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
Guinea Pig
Maximization | ISO 10993-10
ISO 10993-10 | Gloves are non-irritating.
Gloves do not display any potential for
sensitization. | |
| Physical
Characteristics: | | | |
| Dimensions
Physical Properties
Freedom from Holes
Powder Residual | ASTM D3577
ASTM D3577
21 CFR 800.20 &
ASTM D3577
ASTM D3577 tested
using ASTM standard
D6124 | Meet requirements
Meet requirements for rubber surgical gloves
Tested in accordance with ASTM D5151
with acceptable results
Gloves meet powder level requirements for
"Powder-Free" designation per ASTM
D3577. Results generated values