(205 days)
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 <161>) | To determine the bacterial endotoxin of each sample meet the requirement of endotoxin limit | <20EU/pair of gloves | Pass. Under the conditions of the test, the bacterial endotoxin of each test article was less than 20 EU/pair. |
| Shelf Life (ASTM D7160-16) | To validate the shelf life of the proposed device | Three years | Pass. Accelerated aging validation were carried out. 13 samples for each lot have already been picked for real-time stability testing at 6th and 9th month of storage. Performance and package before and after aging were acceptable and met the requirements. |
2. Sample Size Used for the Test Set and Data Provenance
- Watertight Test (ASTM D5151-19): "750 gloves have been tested."
- Irritation (ISO 10993-10): "contact with the skin surface of rabbits." (Specific number not provided, but implies animal testing)
- Systemic toxicity (ISO 10993-11): "following injection into mice." (Specific number not provided, but implies animal testing)
- Pyrogen (ISO 10993-11): "febrile reaction in the rabbit" (Specific number not provided, but implies animal testing)
- Shelf Life (ASTM D7160-16): "13 samples for each lot have already been picked for real-time stability testing". The number of lots is not specified.
- Other mechanical and chemical tests (dimensions, tensile strength, elongation, stress, residual power, aqueous soluble protein content, bacterial endotoxin): Sample sizes are not explicitly stated for these tests in the provided document, beyond the general statement that tests were "conducted to adequately demonstrate the effectiveness of the device."
- Data Provenance: The document does not explicitly state the country of origin for the test data. However, the applicant is "Suzhou Colour-way New Material Co., Ltd." in CHINA, and the submission correspondent is in Shanghai, China. The tests are non-clinical (laboratory/animal-based) rather than human clinical trials. All experiments appear to be prospective, laboratory tests conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This document describes technical and biological performance testing (non-clinical) of a medical device (surgical gloves). It does not involve human expert consensus for a "ground truth" in the way a diagnostic AI study would. The acceptance criteria are based on established international standards (ASTM, ISO, USP). The "ground truth" for these tests is the objective measurement against these published standards.
4. Adjudication Method for the Test Set
Not applicable. This is not a study that involves human readers or an adjudication process for subjective interpretation of data. The tests are objective measurements against defined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is typically for evaluating the effectiveness of a diagnostic tool, often an AI algorithm, by comparing human readers' performance with and without AI assistance. This document is for a physical medical device (surgical gloves) and involves non-clinical performance and biocompatibility testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This is not an AI algorithm. It is a physical medical device.
7. The Type of Ground Truth Used
The ground truth used for all tests is based on established international standards and specifications (ASTM D3577-19, ASTM D5151-19, ASTM D6124-06 (Reapproved 2017), ASTM D5712-2015, ISO 10993-05, ISO 10993-10, ISO 10993-11, USP 43 <161>, 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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
March 23, 2023
Suzhou Colour-way New Material Co., Ltd. % Ivv Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14 th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K222620
Trade/Device Name: Sterilized Latex Surgical Gloves Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO Dated: February 24, 2023 Received: February 24, 2023
Dear Ivy Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222620
Device Name Sterilized Latex Surgical Gloves
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary
K222620
(As requirement by 21 CFR 807.92)
Date prepared: March 23, 2023
A. Applicant:
Name: Suzhou Colour-way New Material Co., Ltd. Address: No. 20, Anmin Road, Huangdai Town, Xiangcheng District 215152, Suzhou City,Jiangsu province, PEOPLE'S REPUBLIC OF CHINA Contact: XU Yongping Title: General Manager Tel: +86- 13862093201/+86-0512-65371017 Email: qa(a)colourway.com
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@@gmail.com
B. Device:
Trade Name: Sterilized Latex Surgical Gloves Model: 6.5.7.7.5.8.8.5.9
Regulatory Information Classification Name: Surgeon's Gloves Classification: Class I Product code: KGO Regulation Number: 21 CFR 878.4460 Review Panel: General Hospital
C. Predicate device:
K212596 Applicant: Amazing Rubber Products Pvt. Ltd. Device Name: Sterile Latex Surgical Gloves Power Free
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Regulatory Information Classification Name: Surgeon's Gloves Classification: Class I Product code: KGO Regulation Number: 21 CFR 878.4460 Review Panel: General Hospital
D. Indications for use of the device:
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.
E. Device Description
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.
| Device | Proposed Device | Predicate Device | Result |
|---|---|---|---|
| 510K # | K222620 | K212596 | - |
| Manufacturer | Suzhou Colour-way New MaterialCo., Ltd. | Amazing Rubber Products Pvt. Ltd. | - |
| Product Name | Sterilized Latex Surgical Gloves | Sterile Latex Surgical Gloves PowerFree | Similar |
| Product Code | KGO | KGO | Same |
| Regulation Number | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Indications for use | The Sterilized Latex Surgical Gloveis a device made of natural rubberintended to be worn by operatingroom personnel to protect a surgicalwound from contamination. | A Sterile Latex Surgical GlovesPowder Free is a device made ofnatural rubber intended to be wornby operating room personnel toprotect a surgical wound fromcontamination. | Same |
| Powder/Powder free | Powder free | Powder free | Same |
| Material | Natural rubber | Natural rubber | Same |
| Classification as perASTM D3577-09,Standard Specification forRubber Surgical Gloves | Type I-gloves coumpounded primaryfrom natural rubber latex | Type I-gloves coumpounded primaryfrom natural rubber latex | |
| Size | 6.57.07.5 | 6.06.57.0 | Similar |
F. Summary of Technological Characteristics
Table 1 General Comparison of Proposed and Predicate Devices
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| 8.0 | 7.5 | ||
|---|---|---|---|
| 8.5 | 8.0 | ||
| 9.0 | 8.5 | ||
| 9.0 | |||
| Sterilization | RadiationSAL-10-6 | ETO/as well as Radiation,SAL-10-6 | Similar |
| Use | Single use | Single use | Same |
| Label and Labeling | Meet FDA's label requirements | Meet FDA's label requirements | Same |
| Type of use | OTC | OTC | Same |
| Shelf-life | Three years | Three years | Same |
Table 2 Technical Comparison of Proposed and Predicate Devices
| Characteristic | Subject device | Predicate deviceK212596 | Comparison |
|---|---|---|---|
| DimensionsLength: Min 265mm | 6.5: 272-278mm7.0: 274-279mm7.5: 276-283mm8.0: 278-284mm8.5: 279-287mm9.0: 282-288mm | 486mm | Different |
| Width | Similar | ||
| 6.5 (83±6mm) | 6.5: 84-85mm | 6.5 (87mm) | |
| 7.0 (89±6mm) | 7.0: 90-92mm | 7.0 (91mm) | |
| 7.5 (95±6mm) | 7.5: 95-97mm | 7.5 (97mm) | |
| 8.0 (102±6mm) | 8.0: 103-105mm | 8.0 (103mm) | |
| 8.5 (108±6mm) | 8.5: 108-110mm | 8.5 (110mm) | |
| 9.0 (114±6mm) | 9.0: 114-116mm | 9.0 (116mm) | |
| Cuff, Palm, Finger TipMin 0.10mm | Cuff: 0.14-0.16mmPalm:0.18-0.21mmFinger: 0.22-0.25mm | Cuff: 0.16mmPalm:0.21mmFinger Tip: 0.33mm | Similar |
| Tensile Strength24Mpa minimum(Before aging) | 26.9-29.3MPa | 28.61Mpa | Similar |
| Ultimate Elongation750% minimum(Before aging) | 800-950% | 871% | Similar |
| Stress at 500%5.5 Mpa Max(Before aging) | 3.3-4.9MPa | 5.1Mpa | Similar |
| Tensile Strength18Mpa minimum(after aging) | 21-26.3MPa | 24.12Mpa | Similar |
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| Ultimate Elongation560% minimum(after aging) | 650-790% | 732% | Similar |
|---|---|---|---|
| Freedom from holesAQL 1.5 | AQL 1.5 | AQL 1.0 | Different |
| Powder residue for powderfree glove powder content<2mg/glove | 1.2-1.5mg/glove | 0.38mg/glove | Different |
| Aqueous ExtractableProtein Content<200ug/dm² | 93.6-125.1 ug/dm² | 46.40 ug/dm² | Different |
| Skin Irritation & SkinSensitization | Non-irritant and non sensitizing | Non-irritant and non sensitizer | Same |
| In-vitro cytotoxicity | Cytotoxic | Cytotoxic | Same |
| Material Mediatedpyrogenicity | Non pyrogenic | Non pyrogenic | Same |
| Systemic toxicity | Under the conditions of study, thedevice extracts do not pose asystemic toxicity concern. | Under the conditions of study,the device extracts do not pose asystemic toxicity concern. | Same |
| Bacterial Endotoxin | <20EU/pair of gloves | <20EU/pair of gloves | Same |
Analvsis:
The subject sterilized latex surgical gloves are substantially equivalent to the predicate device, in terms of indications for use, material composition, sizes, shelf-life and performance. The length and powder residue of the gloves are slightly different from those of the predicate device. But the proposed gloves have been tested according to ASTM D3767 (03)-2014 for dimensions and ASTM D6124-06 (2017) for powder residue respectively, and both dimensions and powder residue met the requirements of ASTM D 3577-19. The protein content of the proposed device is larger than that of the predicate device. However, the proposed device doesn't have special label claim of 50 ug/dm² or less per glove of extractable protein and has been conducted the testing of aqueous extractable protein contenct according to ASTM D5712 and met its requirement.
In addition, the proposed device use different AQL of water tightness test to the predicate device, but the AQL 1.5 is complied with the ASTM D 3577-19 and ASTM D5151-19, and can demonstrate the effectiveness of the proposed device.
Thus, such differences won't raise any concerns of safety and effectiveness of the proposed device.
G. Summary of Non-Clinical Testing
Biocompatibility A
Biocompatibility Testing according to ISO 10993-1:2018, the nature of body contact for the subject device is
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Surface Device category, Skin Contact and duration of contact is A-Limited (≤24h). The following tests for the subject device were conducted to evaluated the biocompatibility of Sterilized Latex Surgical Gloves:
• ISO 10993-05:2009 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity
· ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation And Skin Sensitization
• ISO 10993-11:2017 Biological evaluation of medical device – Part 11: Tests for systemic toxicity
> Performance Testing
Physical performance testing of the proposed device were conducted as per ASTM D3577-19 Standard Specification for Rubber Surgical Gloves. Extractable Protein Test was conducted to for the determination of protein levels in the gloves according to ASTM D5712-2015 Standard Test Method for Analysis of Aqueous Extractable Protein in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method.
To summarize, the performance testing of the subject device were conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:
· ASTM D3577-19 Standard Specification for Rubber Surgical Gloves.
· ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
· ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
· ASTM D5712-2015 Standard Test Method for Analysis of Aqueous Extractable Protein in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method
· ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
· ASTM D3078-02 (2013) Standard Test Method for Determination of Leakage in Flexible Packaging by Bubble Emission Method
• ASTMF88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
- · ASTM D7160-16 Determination of Expiration Date for Medical Gloves
Performance testing and biocompatibility testing are summarized in below table 3.
| Test Methodology | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| DimensionASTM D3577-09 | To determine the lengthof the gloves | 265mm, min | Pass6.5: 272-278mm7.0: 274-279mm7.5: 276-283mm8.0: 278-284mm8.5: 279-287mm9.0: 282-288mm |
| To determine the widthof the gloves | Size 6.5: 83 ± 6 mmSize 7: 89 ± 6 mmSize 7.5: 95 ± 6 mm | Pass6.5: 84-85mm7.0: 90-92mm7.5: 95-97mm | |
| Size 8: 102 ± 6 mm | 8.0: 103-105mm | ||
| Size 8.5: 108 ± 6 mm | 8.5: 108-110mm | ||
| Size 9: 114 ± 6 mm | 9.0: 114-116mm | ||
| To determine thethickness of the gloves | Pass | ||
| Palm:0.10, min | Cuff: 0.14-0.16mm | ||
| Finger: 0.10 min | Palm:0.18-0.21mm | ||
| Cuff: 0.10 min | Finger: 0.22-0.25mm | ||
| To determine thephysical property oftensile strength of thegloves | Before Aging | Pass | |
| Tensile strength 24Mpamin for all sizes | Before Aging26.9-29.3MPa or all sizes | ||
| After Aging | After Aging | ||
| Tensile strength 18Mpamin for all sizes | 21-26.3MPa for all sizes | ||
| Physical PropertiesASTM D3577-09 | To determine thephysical property ofultimate elongation of thegloves | Before Aging750% min for all sizes | Before Aging800%-950% for all sizes |
| After Aging560% min for all sizes | After Aging650%-790%for all sizes | ||
| To determine thephysical properties ofstress at 500% elongationof the gloves | Before Aging5.5Mpa, max for all sizes | Before Aging3.3-4.9MPa | |
| Watertight TestASTM D5151-19 | To determine thewatertightness of thegloves | AQL 1.5 | PassNo glove appears leakage forthe size of 750 gloves havebeen tested. |
| Residual powerASTM D6124-06(17) | To determine the residualpower in the gloves. | 2mg per glove or less | Pass1.2-1.5mg/glove for all testedgloves |
| Aqueous solubleprotein contentASTM D5712-15 | To determine theaqueous soluble proteincontent in the gloves | 200 $µ$ g/dm² max for allsizes. | Pass93.6-125.1 ug/dm² for all testedgloves. |
| IrritationISO 10993-10 | To evaluate the potentialskin irritation caused bytest article contact withthe skin surface ofrabbits. | Negligibly irritating | PassUnder the condition of thisstudy, the device is negligiblyirritating. |
| SensitizationISO 10993-10 | The test was designed toevaluate the potential of atest article to cause skinsensitization. | Non-sensitizing | PassUnder the conditions of thestudy, the device isnon-sensitizing |
| Systemic toxicityISO 10993-11 | The test article wasevaluated to determinewhether leachables | Non-systemic toxicity | PassUnder the conditions of thestudy, there is no mortality or |
| extracted from the testarticle would cause acutesystemic toxicityfollowing injection intomice. | evidence of systemic toxicityfrom the extracts. | ||
| PyrogenISO 10993-11 | The test article wasevaluated for the risks offebrile reaction in therabbit to theadministration byinjection. | Non-pyrogenic | PassUnder the conditions of thestudy, the test articles would notconsidered be febrile reaction. |
| Bacterial EndotoxinUSP 43 <161> | To determine thebacterial endotoxin ofeach sample meet therequirement of endotoxinlimit. | <20EU/pair of gloves | PassUnder the conditions of the test,the bacterial endotoxin of eachtest article was less than 20EU/pair. |
| Shelf lifeASTM D7160-16 | To validate the shelf lifeof the proposed device. | Three years | PassAccelerated aging validationwere carried out to the sterilizedlatex surgical gloves. Inaddition, 13 samples for eachlot have already been picked forreal-time stability testing at 6thand 9th month of storage.Performance and packagebefore and after aging wereacceptable and met therequirements. |
Table 3: Summary of Performance Testing & Biocompatibility Testing
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H. Clinical Test Conclusion
No clinical study is included in this submission.
I. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Sterilized Latex Surgical Gloves is as safe, as effective, and performs as well as the legally marketed predicate device cleared under K212596.
§ 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).