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510(k) Data Aggregation
(205 days)
Sterilized Latex Surgical Gloves
The Sterilized Latex Surgical Glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
The proposed sterilized latex surgical gloves are powder-free, sterile, single use, surgical gloves intended to be worn by operating room personnel to protect a surgical wound from contamination. The gloves are natural color (no colorant added). The gloves are offered in sizes of 6.5, 7, 7.5, 8, 8.5, 9. The gloves are designed and manufactured in accordance with the ASTM D3577-19 standard.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Sterilized Latex Surgical Gloves (Suzhou Colour-way New Material Co., Ltd.)
Predicate Device: Sterile Latex Surgical Gloves Power Free (Amazing Rubber Products Pvt. Ltd.)
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimension (ASTM D3577-09) | To determine the length of the gloves | 265mm, min | Pass. 6.5: 272-278mm; 7.0: 274-279mm; 7.5: 276-283mm; 8.0: 278-284mm; 8.5: 279-287mm; 9.0: 282-288mm |
| To determine the width of the gloves | Size 6.5: 83 ± 6 mm | Pass. 6.5: 84-85mm | |
| Size 7: 89 ± 6 mm | Pass. 7.0: 90-92mm | ||
| Size 7.5: 95 ± 6 mm | Pass. 7.5: 95-97mm | ||
| Size 8: 102 ± 6 mm | Pass. 8.0: 103-105mm | ||
| Size 8.5: 108 ± 6 mm | Pass. 8.5: 108-110mm | ||
| Size 9: 114 ± 6 mm | Pass. 9.0: 114-116mm | ||
| To determine the thickness of the gloves | Palm: 0.10 min; Finger: 0.10 min; Cuff: 0.10 min | Pass. Cuff: 0.14-0.16mm; Palm: 0.18-0.21mm; Finger: 0.22-0.25mm | |
| Physical Property (ASTM D3577-09): Tensile Strength | To determine the physical property of tensile strength of the gloves | Before Aging: 24Mpa min for all sizes | Pass. Before Aging: 26.9-29.3MPa for all sizes |
| After Aging: 18Mpa min for all sizes | Pass. After Aging: 21-26.3MPa for all sizes | ||
| Physical Property (ASTM D3577-09): Ultimate Elongation | To determine the physical property of ultimate elongation of the gloves | Before Aging: 750% min for all sizes | Pass. Before Aging: 800%-950% for all sizes |
| After Aging: 560% min for all sizes | Pass. After Aging: 650%-790% for all sizes | ||
| Physical Property (ASTM D3577-09): Stress at 500% | To determine the physical properties of stress at 500% elongation of the gloves | Before Aging: 5.5Mpa, max for all sizes | Pass. Before Aging: 3.3-4.9MPa |
| Watertight Test (ASTM D5151-19) | To determine the watertightness of the gloves | AQL 1.5 | Pass. No glove appears leakage for the size of 750 gloves have been tested. |
| Residual Power (ASTM D6124-06 (17)) | To determine the residual power in the gloves | 2mg per glove or less | Pass. 1.2-1.5mg/glove for all tested gloves |
| Aqueous Soluble Protein Content (ASTM D5712-15) | To determine the aqueous soluble protein content in the gloves | 200 µg/dm² max for all sizes | Pass. 93.6-125.1 ug/dm² for all tested gloves |
| Irritation (ISO 10993-10) | To evaluate the potential skin irritation caused by test article contact with the skin surface of rabbits | Negligibly irritating | Pass. Under the condition of this study, the device is negligibly irritating. |
| Sensitization (ISO 10993-10) | The test was designed to evaluate the potential of a test article to cause skin sensitization | Non-sensitizing | Pass. Under the conditions of the study, the device is non-sensitizing |
| Systemic Toxicity (ISO 10993-11) | The test article was evaluated to determine whether leachables extracted from the test article would cause acute systemic toxicity following injection into mice | Non-systemic toxicity | Pass. Under the conditions of the study, there is no mortality or evidence of systemic toxicity from the extracts. |
| Pyrogen (ISO 10993-11) | The test article was evaluated for the risks of febrile reaction in the rabbit to the administration by injection | Non-pyrogenic | Pass. Under the conditions of the study, the test articles would not be considered be febrile reaction. |
| Bacterial Endotoxin (USP 43 ) | To determine the bacterial endotoxin of each sample meet the requirement of endotoxin limit | , ASTM D7160-16). These standards define the acceptable quantitative or qualitative outcomes for each test. |
8. The Sample Size for the Training Set
Not applicable. This is not an AI algorithm study; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for it.
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(336 days)
Disposable Sterilized Latex Surgical Gloves
The Disposable Sterilized Latex Surgical Glove is a device made of nature rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
The proposed device, Disposable Sterilized Latex Surgical Gloves is a sterilized and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination. The proposed device is made of natural rubber latex, per standard ASTM D3577-09(15), the rubber surgical gloves classification is: "Type 1-gloves compounded primarily from nature rubber latex." The gloves are powder-free and available in white in sizes 6, 6.5, 7, 7.5, 8, and 8.5. The proposed device is provided EO sterilized to achieve the sterility Assurance Level (SAL) of 106. The disposable sterilized latex surgical glove shelf life is 3 years.
This document is a 510(k) summary for Disposable Sterilized Latex Surgical Gloves, demonstrating substantial equivalence to a predicate device (K171550). It focuses on non-clinical performance data and does not involve AI or clinical studies as typically defined in medical imaging or diagnostic device contexts. Therefore, many of the requested points are not applicable.
Here's an analysis of the provided information in the context of the requested questions:
Acceptance Criteria and Device Performance
This product is a medical device (Disposable Sterilized Latex Surgical Gloves), not an AI algorithm. The "acceptance criteria" and "reported device performance" are based on physical, chemical, and biological properties of the gloves, compared against recognized ASTM and ISO standards.
Table of Acceptance Criteria and Reported Device Performance:
| Test Method (Standard) | Test Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Dimension | |||
| ASTM D3577-09(Reapproved 2015) | Determine length of gloves | 265mm, min | Pass |
| ASTM D3577-09(Reapproved 2015) | Determine width of gloves | Size 6: 76 ±6 mm; Size 6.5: 83 ± 6 mm; Size 7: 89 ± 6 mm; Size 7.5: 95 ± 6 mm; Size 8: 102 ± 6 mm; Size 8.5: 108 ± 6 mm | Pass |
| ASTM D3577-09(Reapproved 2015) | Determine thickness of gloves | Palm: 0.10mm, min; Finger: 0.10mm, min; Cuff: 0.10mm, min | Pass |
| Physical Properties | |||
| ASTM D3577-09(Reapproved 2015) | Determine physical properties (Tensile strength) | Before Ageing Tensile Strength: 24Mpa Minimal for all sizes; After Ageing Tensile Strength: 18Mpa Minimal for all sizes | Pass |
| ASTM D3577-09(Reapproved 2015) | Determine physical properties (Ultimate Elongation) | Before Ageing Ultimate Elongation: 750% Min for all sizes; After Ageing Ultimate Elongation: 560% Min for all sizes | Pass |
| Watertight test | |||
| ASTM D5151-19 | Determine watertightness of gloves | Sample size: 200 pcs; Inspection level: GI; AQL 1.5; Criteria: ≤8 pieces | Pass |
| Residual powder | |||
| ASTM D6124-06 (Reapproved 2017) | Determine residual powder in gloves | 2 mg per glove or less | Pass |
| Protein content | |||
| ASTM D5712 - 15 | Determine extractable protein in gloves | 200 µg/dm² Max for all sizes | Pass |
| Biocompatibility | |||
| ISO 10993-10 | Evaluate potential of a test article to cause skin sensitization | Under the conditions of the study, not a sensitizer | Pass |
| ISO 10993-10 | Evaluate potential skin irritation caused by test article contact with skin surface of rabbits | Under the condition of study, not an irritant | Pass |
| ISO 10993-11:2017 | Evaluate whether leachables extracted from the test article would cause acute systemic toxicity following injection into mice | Under the conditions of study, the device extracts do not pose a systemic toxicity concern | Pass |
| USP 43-NF 38 | Evaluate risks of febrile reaction in the rabbit to administration by injection | Under the condition of study, not a pyrogen | Pass |
| USP 43 | Bacterial Endotoxin Test |
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