(90 days)
Not Found
No
The summary describes a physical medical device (surgical gloves) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a surgeon's glove intended to protect a surgical wound from contamination, not to treat or mitigate a disease or condition.
No
Explanation: This device is a surgeon's glove, intended to protect a surgical wound from contamination, not to diagnose a condition.
No
The device is a surgical glove, which is a physical hardware device made of natural rubber. The summary describes its material composition, physical properties, and performance characteristics related to its physical form. There is no mention of software components.
No, this device is not an IVD (In Vitro Diagnostic).
The provided text describes a surgical glove intended to be worn by operating room personnel to protect a surgical wound from contamination. This is a physical barrier device used during surgery.
IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. The description of this surgical glove does not involve any such testing of biological specimens.
N/A
Intended Use / Indications for Use
This powder-free 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 sterile. It is made with natural rubber latex. The glove is coated with nitrile coating. The glove is manufactured using exact same material used in the currently cleared device, Protegrity Blue glove (K053272). 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.
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)
Non-clinical tests were conducted for determination of substantial equivalence.
Biocompatibility tests (Primary Skin Irritation per ISO 10993-10 and Guinea Pig Maximization per ISO 10993-10) showed the gloves are non-irritating and do not display any potential for sensitization.
Physical Characteristics tests (Dimensions per ASTM D3577, Physical Properties per ASTM D3577, Freedom from Holes per 21 CFR 800.20 & ASTM D3577, Powder Residual per ASTM D3577 tested using ASTM standard D6124, Protein Content per ASTM D5712, FDA Medical Glove Guidance Manual) showed the gloves meet all requirements.
Clinical data is not required.
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
§ 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 9 2011
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 is made up of several curved lines that converge and overlap. The text "CardinalHealth" is written in a bold, sans-serif font.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS For STERILE LATEX WITH NITRILE COATING 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)
| Applicant: | Cardinal Health |
|---|---|
| 1430 Waukegan Road | |
| McGaw Park, IL 60085 | |
| Establishment Registration |
| 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 Protexis™ Latex Blue with Neu-Thera® Surgical Gloves Trade Name: 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 Protegrity® Blue Sterile Powder-Free Latex/Nitrile Surgical Gloves with Neu-Thera Coating and with Protein Content Label Claim of 50 is claimed: micrograms or less (510(k) K053272, product code KGO) Reason for 510(k) Modification of a legally marketed device Submission:
Device Description: The proposed device is a disposable device intended for over the counter use and is provided powder-free sterile. It is made with natural rubber latex. The glove is coated with nitrile coating. The glove is manufactured using exact same material used in the currently cleared device, Protegrity Blue glove (K053272). 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.
1
Intended Use:
This powder-free 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.
| Summary of the technological characteristics of the device compared to the predicate device | ||
|---|---|---|
| Characteristic | Modified Device | Original (Predicate) |
| Characteristic | Sterile Latex with Nitrile Coating | |
| Powder-Free Blue Surgical Gloves | ||
| with Neu-Thera Coating | Protegrity Blue Sterile Latex/Nitrile | |
| Powder-Free Surgical Glove with | ||
| Neu-Thera Coating (K053272) | ||
| Material | ||
| Composition | Natural Rubber Latex coated with | |
| Nitrile | Natural Rubber Latex coated with | |
| Nitrile | ||
| 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 | ||
| Protein Contents | Contains less than 50 $ \mu g/dm^2 $ of | |
| total water extractable protein per | ||
| glove as tested per ASTM D5712 | Contains less than 50 $ \mu g/dm^2 $ 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 | Gloves are non-irritating. |
| Guinea Pig | ISO 10993-10 | Gloves do not display any potential for |
Cardinal Health, Inc. Premarket Notification Submission – Special 510(k)
2
K/11878
| Maximization | 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 |