(336 days)
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<151> | Evaluate risks of febrile reaction in the rabbit to administration by injection | Under the condition of study, not a pyrogen | Pass |
| USP 43 <85> | Bacterial Endotoxin Test | <20 EU/ pair of gloves | Pass |
| Sterilization Residuals | |||
| ISO 10993-7:2008 | Determine if Ethylene Oxide residues of test article are within requirements | ≤10ug/cm² | Pass |
| ISO 10993-7:2008 | Determine if Ethylene Chlorohydrin residues of test article are within requirements | ≤5mg/cm² | Pass |
1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set:
- For the Watertight test (ASTM D5151-19), the sample size was 200 pieces.
- Other tests (e.g., dimensions, physical properties, residual powder, protein content, biocompatibility, sterilization residuals) refer to specific ASTM/ISO standards. While the standards themselves define sampling plans, the document does not explicitly state the exact sample size used for each of these specific tests beyond the watertight test.
- Data Provenance: The document does not specify the country of origin of the data (other than the manufacturer being in China) or whether the studies were retrospective or prospective. Given the nature of mechanical/chemical testing of medical devices, these are typically prospective laboratory tests conducted to specific standard protocols.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This is a medical device (surgical gloves) undergoing non-clinical performance and biocompatibility testing, not an AI algorithm requiring expert ground truthing of images or clinical data. The "ground truth" here is defined by physical, chemical, and biological measurement standards (ASTM, ISO, USP).
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As above, this is non-clinical device testing, not a study involving human interpretation or consensus. The "adjudication" is based on meeting pre-defined numerical or qualitative criteria from recognized standards.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This document pertains to the clearance of a physical medical device (surgical gloves), not an AI algorithm. Therefore, no MRMC study was conducted.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This document pertains to the clearance of a physical medical device (surgical gloves), not an AI algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests, the "ground truth" is defined by the established criteria within the cited ASTM, ISO, and USP standards. For example:
- Dimensions are compared to specified minimums/ranges.
- Tensile strength is compared to specified minimal MPa.
- Watertightness is determined by meeting an AQL (Acceptance Quality Limit) of 1.5, meaning a certain percentage of defects is acceptable.
- Biocompatibility (sensitization, irritation, systemic toxicity, pyrogenicity, endotoxin) is determined by standardized biological test methods with defined pass/fail criteria (e.g., "not a sensitizer," "not an irritant," "no systemic toxicity concern," "<20 EU/pair of gloves").
- Protein and residual chemical content are compared to specified maximum limits.
7. The sample size for the training set
- Not Applicable. This is not an AI algorithm; there is no "training set."
8. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not relevant.
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May 25, 2022
Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd % Alice Huang RA Manager Shanghai Mind-Link Business Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District Shanghai. 200040 China
Re: K211953
Trade/Device Name: Disposable 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: April 15, 2022 Received: April 25, 2022
Dear Alice Huang:
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.
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
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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, M.D., Ph.D. Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K211953
Device Name Disposable Sterilized Latex Surgical Gloves
Indications for Use (Describe)
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.
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
K211953
I. SUBMITTER:
Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. No. 316 National road, Xinju, Changshan Town, Jinxian County, Nanchang City, 331724, Jiangxi Province, China. Contact Person: Jenny Huang
TITLE: International Trade Supervisor
TEL. : +86 17702094798
Email: sales@jxkmjt.com
Submission Correspondent: Alice Huang Email: alice.huang(@mind-link.net Tel:+86 15618536177 Shanghai Mind-link Business Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District, Shanghai
Summary prepared: 05/23/2022
II. DEVICE 510(k) Number: K211953 Name of Device: Disposable Sterilized Latex Surgical Gloves Regulation Number: 21 CFR878.4460 Common Name: Surgeon's Gloves Classification Name: Non-powdered surgeon's glove Regulatory Class: I Product Code: KGO
III. PREDICATE DEVICE
510(k) Number: K171550 Product Name: Sterile Latex Surgical Gloves, Powder Free Manufacture: Sanrea Healthcare Pvt Ltd
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IV. DEVICE DESCRIPTION
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.
V. INDICATIONS FOR USE
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.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Disposable Sterilized Latex Surgical Gloves are compared with the predicate device (Sterile Latex Surgical Gloves, Powder Free, K171550). The results are shown below in the Technological Characteristics Comparison Table:
| DEVICE | Subject Device | Primary Predicate Device(K171550) | Comparison |
|---|---|---|---|
| Indications For Use | 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 Sterile Latex Surgical Gloves, Powder free, is a disposable device made of natural rubber, intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination. | Same |
| Intended Use | 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. | Intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination. | Same |
| ClassificationProduct Code | KGO | KGO | Same |
| Regulation No. | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Class | I | I | Same |
| Powdered orPowdered free | Powdered free | Powdered free | Same |
| Material | Natural Rubber Latex | Natural Rubber Latex | Same |
| Dimensions | Length:Size 6: 265mm, minSize 6.5: 265mm, minSize 7: 265mm, minSize 7.5: 265mm, minSize 8: 265mm, minSize 8.5: 265mm, minWidth:Size 6: 76 ±6 mmSize 6.5: 83 ± 6 mmSize 7: 89 ± 6 mmSize 7.5: 95 ± 6 mmSize 8: 102 ± 6 mmSize 8.5: 108 ± 6 mmPalm Thickness: 0.10mm, minFinger Thickness: 0.10mm, minCuff Thickness: 0.10mm, min | size 7.5 :Length : 300mmsize 7.5 :Width : 95mmPalm Thickness: 0.19mmFinger Thickness: 0.22mmCuff Thickness: 0.14mm | SimilarMeetingrequirementof ASTMD 3577 |
| Biocompatibility | Under the conditions of the study, not a sensitizer.Under the conditions of the study, not an irritant.Under the conditions of the study, no evidence of acute systemic toxicity. | Non-sensitizingNon-irritating | Similar |
| Tensile strength | Before Aging 24MPa, minAfter Aging 18MPa, min | Before Aging 31.22MPaAfter Aging 24.43MPa | SimilarMeeting |
| UltimateElongation | Before Aging 750%, minAfter Aging 560%,min | Before Aging 843.09%After Aging 762.28% | requirementof ASTMD 3577 |
| Freedom from | Meets ASTM D5151-06(2015) | Meets ASTM D 5151 -06 | Same |
| Holes | AQL 1.5 | (2011) | |
| Protein Content | Meets ASTM D5712-2015 | Meets ASTM D5712 | Same |
| Powdered residue | Meets ASTM D6124-06(Reapproved 2017) | Meets ASTM D 6124-06(2011) | Same |
| Sterility | EO | EO | Same |
| EtO and ECH residuals | Meets ISO 10993-7:2008 | Meets ISO 10993-7:2008 | Same |
| Shelf life | 3 Years | 3 Years | Same |
| Single Use | YES | YES | Same |
| Label and labeling | Meet FDA's Requirement | Meet FDA's Requirement | Same |
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VII. SUMMARY OF NON-CLINICAL TESTING
The gloves have the same technological characteristics compared to ASTM or equivalent standards as given below:
- ASTM D5151-06(Reapproved 2015) 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 D3577-09 (Reapproved 2015) Standard Specification for Rubber Surgical Gloves
- . ASTM D5712-15 Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method
- ISO 10993-1 : 2009 Biological evaluation of medical devices - Part1: Evaluation and testing within a risk management process
- ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- USP 43-NF 38<151> Pyrogen Test
- USP 43<85> Bacterial Endotoxin Test
- ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
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- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- . ASTM D7160 Standard Practice for Determination of Expiration Dating for medical Gloves
| TestMethod | Standard | Test Purpose | Criteria | Result |
|---|---|---|---|---|
| Dimension | ASTM D3577-09(Reapproved2015) Standard Specification forRubber Surgical Gloves | To determine the lengthof the gloves | 265mm, min | Pass |
| ASTM D3577-09(Reapproved2015)Standard Specification forRubber Surgical Gloves | To determine the widthof the gloves | Size 6: 76 ±6 mmSize 6.5: 83 ± 6 mmSize 7: 89 ± 6 mmSize 7.5: 95 ± 6 mmSize 8: 102 ± 6 mmSize 8.5: 108 ± 6 mm | Pass | |
| ASTM D3577-09(Reapproved2015) Standard Specification forRubber Surgical Gloves | To determine thethickness of the gloves | Palm: 0.10mm, minFinger: 0.10mm, minCuff: 0.10mm, min | Pass | |
| PhysicalProperties | ASTM D3577-09(Reapproved2015) Standard Specification forRubber Surgical Gloves | To Determine thephysical propertiesTensile strength | Before AgeingTensile Strength24Mpa Minimal for allsizesAfter AgeingTensile Strength18Mpa Minimal for allsizes | Pass |
| ASTM D3577-09(Reapproved2015) Standard Specification forRubber Surgical Gloves | To Determine thephysical propertiesUltimate Elongation | Before AgeingUltimate Elongation750% Min for all sizesAfter AgeingUltimate Elongation560% Min for all sizes | Pass | |
| Watertighttest | ASTM D5151-19 Standard TestMethod for Detection of Holes inMedical Gloves | To determine thewatertightness of the testgloves | Sample size: 200 pcsInspection level : GIAQL 1.5Criteria:≤8 pieces | Pass |
| Residualpowder | ASTM D6124-06 (Reapproved2017) Standard Test Method for | To determine theresidual powder in the | 2 mg per glove or less | Pass |
| Residual Powder on MedicalGloves | gloves | |||
| Proteincontent | ASTM D5712 - 15, Standard TestMethod for Analysis of AqueousExtractable Protein in NaturalRubber. | To determine theextractable protein in thegloves. | $200 \mu g/dm^2$ Max forall sizes | Pass |
| SkinSensitization | ISO 10993-10Biological Evaluation ofMedical Devices Test forIrritation and SkinSensitization. Test donefor irritation | The test was designed toevaluate the potential ofa test article to causeskin sensitization. | Under the conditionsof the study not asensitizer | Pass |
| Irritation | ISO 10993-10Biological Evaluation ofMedical Devices Test forIrritation and SkinSensitization. Test donefor irritation | To evaluate the potentialskin irritation caused bytest article contact withthe skin surface ofrabbits. | Under the condition ofstudy not an irritant | Pass |
| Systemictoxicity | ISO 10993-11:2017 biologicalevaluation of medical devices - part11, tests for systemic toxicity | The test article wasevaluated to determinewhether leachablesextracted from the testarticle would cause acutesystemic toxicityfollowing injection intomice. | Under the conditionsof study the deviceextracts do not pose asystemic toxicityconcern | Pass |
| Pyrogen | USP 43-NF 38<151> Pyrogen Test | The test article wasevaluated for the risks offebrile reaction in therabbit to theadministration byinjection. | Under the condition ofstudy not a pyrogen | Pass |
| BacterialEndotoxin | USP 43 <85> BacterialEndotoxinTest | Bacterial EndotoxinTest | <20 EU/ pair of gloves | Pass |
| EO Residue | ISO 10993-7:2008 | Determine if theEthylene Oxide residuesof test article is withinthe requirements. | ≤10ug/cm² | Pass |
| ECHResidue | ISO 10993-7:2008 | Determine if theEthylene Chlorohydrin | ≤5mg/cm² | Pass |
| residues of test article iswithin the requirements. |
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VIII. SUMMARY OF CLINICAL TESTING No clinical testing is included in this submission.
IX. CONCLUSION
The conclusions drawn from the non-clinical performance data demonstrate that the subject device, Disposable Sterilized Latex Surgical Glove, is as safe, as effective, and performs as well as or better than the legally marketed predicate device K171550.
§ 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).