(114 days)
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Not Found
No
The device is a surgical glove and the summary describes standard testing for gloves, with no mention of AI or ML.
No.
The device is a surgical glove, which is a barrier and protective device, not one designed to treat or cure a disease or condition.
No
Explanation: The device is described as a "single use disposable sterile surgical glove" and its intended use is for surgical procedures, not for diagnosis. The performance studies focus on physical properties, safety, and regulatory compliance for gloves, not diagnostic accuracy.
No
The device is described as a physical surgical glove made of 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 clearly stated as a "single use disposable sterile surgical glove." This is a medical device used for barrier protection during surgical procedures, not for diagnosing diseases or conditions using samples from the human body.
- Device Description: The description confirms it's a "Powder-free Latex Surgical Glove." This aligns with the intended use and not with the typical components of an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements associated with in vitro diagnostic testing.
Therefore, this device falls under the category of a surgical glove, which is a medical device but not an IVD.
N/A
Intended Use / Indications for Use
This device is intended to be used as a single use disposable sterile surgical glove.
Product codes (comma separated list FDA assigned to the subject device)
79KGO
Device Description
Powder-free Latex Surgical Gloves which meets the requirements of ASTM D 3577-91.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The standards used for Glovel Gx, Powder-free Latex Surgical Gloves production are based on ASTM-D-3577-91. All tests meet requirements of Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 2.5. The FDA 1000 ml Water Fill Test was also conducted with samplings of AQL 1.5, Inspection Level I meeting these requirements. Primary Skin Irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
NOV 27 1996
Exhibit #1 Page 1 of 3
510(k) Summary
This summary of 53 Q(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: } 9 6 30 2 (
- ubmitter's Identification:
C. Alva Kemwell International Ltd. 3B, Peenya, II Phase Bangalore 560 058, India
10th July 1996
Date Summary Prepared:
Name of the Device:
GLOVEL Gx Powder-free Latex Surgical Gloves.
Predicate Device Information:
Device Description;
Class | Powder-free Latex Surgical Gloves which meets the requirements of ASTM D 3577-91. The equivalent device identified in the market is SAFESKIN-SUPRA of Safeskin i Corporation, USA.
Classification by FDA's General and Plastic Surgery Device Panel as Class 1, 21 CFR 878.4460, Surgical Powder-free Latex Gloves, 79KGO, and meets all requirements of ASTM Standard D-3577-91.
This device is intended to be used as a single use disposable sterile surgical glove.
Intended Use:
1
Exhibit #1 Page 2 of 3
Comparison to Predicate
-
- 317
Device:
Kemwell International Ltd. Powder-free Latex Surgical Gloves is substantially equivalent in safety and effectiveness to the Gloves sold by Safeskin Corporation USA, the brand name SAFESKIN-SUPRA.
Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
The standards used for Glovel Gx, Powder-free Latex Surgical Gloves production are based on ASTM-D-3577-91. All tests meet requirements of Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 2.5.
The FDA 1000 ml Water Fill Test was also conducted with samplings of AQL 1.5, Inspection Level I meeting these requirements. Primary Skin Irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.
There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels.
Method of Sterilization: Ethylene Oxide
Methodology Used:
EN550 Equivalent to AAMI/ANSI/ISO-11145-1994 Standard.
Sterility Assurance Level: 10-6
arameters Employed:
oncentration:
750 mg/L
2
| Exhibit #1 | Page 3 of 3 |
|---|---|
| Exposure Time: | 6 hrs. |
| Temperature: | 55-60°C |
| RH: | 50% (min) |
- Discussion of Clinical Tests Performed:
Not applicable - there is no hypoallergenic claim.
- Conclusion:
Kemwell International Ltd. Powder-free Latex Surgeon's Gloves conform fully to
ASTM-D-3577-91 standards as well as applicable 21 CFR references, and,
meets pinhole FDA requirements, biocompatibility requirements and labeling
claims as shown by data in our 510(k). There are no safety/efficacy issues or
new claims from the "Substantial Equivalence" products cited.
Based on the non-clinical tests our product has demonstrated to be as safe and
effective as our predicate device.
.