(127 days)
The Single-Use Latex Sterile Surgical Gloves are device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
The proposed device, Single-Use Latex Sterile 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-qloves compounded primarily from nature rubber latex." The qloves are powderfree and available in white in sizes 6, 6.5, 7, 7.5, 8, 8.5 and 9. The proposed device is provided Radiation sterilized to achieve the sterility Assurance Level (SAL) of 10-6. The latex surgical glove shelf life is 3 years.
This document is a 510(k) Pre-market Notification for a medical device, specifically Single-Use Latex Sterile Surgical Gloves (SG100). It focuses on demonstrating substantial equivalence to a predicate device, not necessarily a comprehensive study proving novel effectiveness.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents two tables relevant to acceptance criteria and device performance:
Table 1: Comparison of Technological Characteristics (Proposed vs. Predicate) - This table indirectly shows performance against standards and similarities with the predicate.
| Characteristic | Acceptance criteria of the standard (Implied or Explicit) | Proposed device K231446 | Predicate device K212848 | Remarks |
|---|---|---|---|---|
| Product name | N/A (Comparison, not an acceptance criterion) | Single-Use Latex Sterile Surgical Gloves | Sterile Latex Surgical Gloves Powder Free | Similar |
| Indications For Use | N/A (Comparison, not an acceptance criterion) | To protect surgical wound from contamination | To protect surgical wound from contamination | Similar |
| Product Code | KGO | KGO | KGO | Same |
| Regulation Number | 21 CFR 878.4460 | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Powdered or Powder free | Powdered free | Powdered free | Powdered free | Same |
| Classification as per ASTM D3577-2019 | Type I - gloves compounded primarily from natural rubber latex | Type I - gloves compounded primarily from natural rubber latex | Type I - gloves compounded primarily from natural rubber latex | Same |
| Type of use | Over the counter use | Over the counter use | Over the counter use | Same |
| Shelf Life | 3 Years | 3 Years | 3 Years | Same |
| Sterilization | Radiation, SAL- 10-6 | Radiation, SAL- 10-6 | Radiation, SAL- 10-6 | Same |
| Single use | Yes | Yes | Yes | Same |
| Label and Labeling | Meet FDA's Requirement | Meet FDA's Requirement | Meet FDA's Requirement | Same |
| Protein Content | N/A (Comparison, predicate has a lower value, but both meet <200µg/dm²) | 141µg/dm² | 50µg/dm² | Similar (Both likely meet the <200µg/dm² requirement though predicate is lower) |
Table 2: Characteristics Comparison including Acceptance Criteria and Performance (This table on pages 6-8 directly addresses performance against standards)
| Characteristics | Acceptance criteria of the standard | Subject device K231446 data (Reported Performance) | Predicate device K212848 data (Reported Performance) | Remarks |
|---|---|---|---|---|
| Dimensions | ||||
| Length: Min 265 mm | Min 265 mm | 281 mm | 380 mm | SimilarMeets ASTM D3577-2019, Standard Specification for Rubber Surgical Gloves |
| Size (e.g., 6.0, 6.5, etc., ±6mm tolerance) | Specified diameters with ±6mm tolerance (e.g., 6.0: 76+/-6mm) | Meets specified diameters (e.g., 6.0: 76mm, 6.5: 84mm, 7.0: 90mm, 7.5: 96mm, 8.0: 102mm, 8.5: 109mm, 9.0: 115mm) | Meets specified diameters (e.g., 6.0: 74mm, 6.5: 86mm, 7.0: 92mm, 7.5: 98mm, 8.0: 105mm, 8.5: 110mm, 9.0: 116mm) | Meets ASTM D3577-2019, Standard Specification for Rubber Surgical Gloves |
| Cuff, Palm, Finger Tip Thickness: Min 0.10 mm | Min 0.10 mm | Cuff- 0.16mmPalm-0.18mmFinger Tip-0.22mm | Cuff- 0.12mmPalm-0.16mmFinger Tip-0.21mm | |
| Physical Properties | ||||
| Tensile Strength Before Aging | 24 Mpa minimum | 37 Mpa | 28.55 Mpa | SimilarMeets ASTM D3577-2019, Standard Specification for Rubber Surgical Gloves |
| Ultimate Elongation Before Aging | 750% minimum | 814% | 870% | SimilarMeets ASTM D3577-2019, Standard Specification for Rubber Surgical Gloves |
| Stress at 500% Before Aging | 5.5 MPa Max | 3.5 Mpa | 5.1 Mpa | SimilarMeets ASTM D3577-2019, Standard Specification for Rubber Surgical Gloves |
| Tensile Strength After Aging | 18 Mpa minimum | 32.49 Mpa | 23.48 Mpa | SimilarMeets ASTM D3577-2019, Standard Specification for Rubber Surgical Gloves |
| Ultimate Elongation After Aging | 560% minimum | 760% | 731% | SimilarMeets ASTM D3577-2019, Standard Specification for Rubber Surgical Gloves |
| Integrity | ||||
| Freedom from Holes | AQL 1.5 | AQL 1.5 | AQL 1.0 | SimilarMeets ASTM D3577-2019 and ASTM D5151-2019, Standard Test Method for Detection of Holes in Medical Gloves |
| Powder residue for powder-free glove | Powder content < 2 mg/Glove | 0.21 mg/Glove | 0.40 mg/Glove | SimilarMeets ASTM D3577-2019 and ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves |
| Biocompatibility | ||||
| Skin Irritation & Skin Sensitization (ISO 10993-10) | Non-irritant and Non-Sensitizer | Non- irritant and Non-Sensitizer | Non- irritant and Non-Sensitizer | Same |
| In vitro cytotoxicity (ISO 10993-5) | (Implied non-cytotoxic, but reported as "Cytotoxic". This is a discrepancy or a nuance in reporting as per usual biocompatibility pass/fail criteria) | Cytotoxic | Cytotoxic | Same (This usually means it fails, which is unusual for a cleared device. Needs clarification in a deeper dive) |
| Material Mediated pyrogenicity (ISO 10993-11 & USP 41) | Non pyrogenic | Non pyrogenic | No data available | --- (Subject device met; predicate data not available) |
| Acute Systemic Toxicity (ISO 10993-11) | Device extracts do not pose an acute systemic toxicity concern | Under the conditions of study the device extracts do not pose an acute systemic toxicity concern | Under the conditions of study the device extracts do not pose an acute systemic toxicity concern | Same |
| Bacterial Endotoxin (USP 42 <85>) | <20EU/pair of gloves | <20EU/pair of gloves | <20EU/pair of gloves | Same |
2. Sample size used for the test set and the data provenance
The document specifies non-clinical tests were conducted according to various ASTM and ISO standards (pages 9-10). These standards define sample sizes for specific tests (e.g., AQL for holes, specific number of samples for physical properties, etc.). However, the exact sample sizes used for each test are not explicitly stated in this document, only that the tests "Meets the requirement" of the standards.
The data provenance is from non-clinical testing performed on the "Subject device K231446", which is a prospective test for this submission. The country of origin of the data is not explicitly stated, but the manufacturer is Fitone Latex Products Co., Ltd. Guangdong, China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This device is a physical product (surgical gloves) and the performance criteria are based on objective measurements defined by international standards (ASTM, ISO, USP). Therefore, no human "experts" are used to establish ground truth in the way one would for diagnostic imaging or clinical assessment. The "ground truth" is the established technical specification in the referenced standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is for objective physical/chemical testing per standards, not for subjective assessments requiring adjudication.
5. 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 device is a surgical glove, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the performance of the surgical gloves is based on international consensus standards and specifications (ASTM D3577-19 for physical properties, ASTM D5151-19 for holes, ASTM D6124-06 for residual powder, ASTM D5712-15 for protein content, ISO 10993 series for biocompatibility, ISO 11137 series for sterilization, and USP standards for bacterial endotoxin and pyrogenicity). These standards define the acceptable range or threshold for each characteristic.
8. The sample size for the training set
Not applicable. This is a physical product, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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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".
September 22, 2023
Fitone Latex Products Co., Ltd. Guangdong % Kvra Kang Director Landlink Healthcare Technology (Shanghai) Co., Ltd Room 1308, Baohua International Plaza, West Guangzhong Road 555. Jingan District Shanghai, 200072 China
Re: K231446
Trade/Device Name: Single-Use Latex Sterile Surgical Gloves (SG100) Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO Dated: September 11, 2023 Received: September 11, 2023
Dear Kyra Kang:
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 medical devices and radiation-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 DHT4B2: Personal Protective Equipment, Reprocessing & Disinfection Devices Team 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Single-Use Latex Sterile Surgical Gloves (SG100)
Indications for Use (Describe)
The Single-Use Latex Sterile Surgical Gloves are 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary
K231446
l. Submitter
Fitone Latex Products Co., Ltd. Guangdong No.5 Huitong road, Lingbei Industrial Zone, Suixi, 524338 Zhanjiang, Guangdong, China
Contact person: Christine Ou Position: Manager Tel.: 0759-7905808 E-mail: market-intl@fitonelatex.com
Preparation date: Sept. 19, 2023
Submission Correspondent
Ms. Kyra Kang Landlink Healthcare Technology (Shanghai) Co., Ltd. E-mail: kyra.kang@landlink-health.com
US Agent
Qihui Zhang ZYPPEL LLC 1337 Massachusetts Avenue #158 Arlington MA, MA US 02476
II. Proposed Device
| Device | Trade Name: Single-Use Latex Sterile Surgical Gloves |
|---|---|
| Model: | SG100 |
| Common name: | Surgeon's Gloves |
| Regulation Number: | 21 CFR 878.4460 |
| Regulatory Class: | Class I |
| Product code: | KGO |
| Review Panel: | General Hospital |
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III. Predicate Device
| 510(k) Number: K212848 | |
|---|---|
| Trade name: | Sterile Latex Surgical Gloves Powder Free |
| Common name: | Surgeon's Gloves Classification: Class I |
| Product Code: | KGO |
| Manufacturer | Pentavest Holdings Sdn Bhd |
IV. Device Description
- The proposed device, Single-Use Latex Sterile 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-qloves compounded primarily from nature rubber latex." The qloves are powderfree and available in white in sizes 6, 6.5, 7, 7.5, 8, 8.5 and 9.
The proposed device is provided Radiation sterilized to achieve the sterility Assurance Level (SAL) of 10-6. The latex surgical glove shelf life is 3 years.
V. Indication for use
The Single-Use Latex Sterile Surgical Glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
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| Characteristic | Proposed deviceK231446 | Predicate deviceK212848 | Discussion |
|---|---|---|---|
| Product name | Single-Use LatexSterile SurgicalGloves | Sterile Latex SurgicalGloves Powder Free | Similar |
| Indications ForUse | The Single-Use LatexSterile Surgical Gloveis a device made ofnatural rubberintended to be wornby operating roompersonnel to protect asurgical wound fromcontamination. | A Sterile Latex SurgicalGloves Powder Free is adevice made of naturalrubber intended to be wornby operating room personnelto protect a surgical woundfrom contamination. | Similar |
| Product Code | KGO | KGO | Same |
| RegulationNumber | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Powdered orPowder free | Powdered free | Powdered free | Same |
| Classification asper ASTMD3577- 2019 | Type I - glovescompounded primarilyfrom natural rubberlatex | Type I - glovescompounded primarily fromnatural rubber latex | Same |
| Type of use | Over the counter use | Over the counter use | Same |
| Shelf Life | 3 Years | 3 Years | Same |
| Sterilization | Radiation, SAL- 10-6 | Radiation, SAL- 10-6 | Same |
| Single use | Yes | Yes | Same |
| Label andLabeling | Meet FDA'sRequirement | Meet FDA's Requirement | Same |
| Protein Content | 141µg/dm² | 50µg/dm² | Similar |
VI. Comparison of Technological Characteristics with the Predicate Device
Table
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| Characteristics | Acceptance criteria of thestandard | Remarks | |
|---|---|---|---|
| Subject deviceK231446 | Predicate deviceK212848 | ||
| Dimensions Length:-Min 265 mm | 281 mm | 380 mm | SimilarMeets ASTM D3577-2019,Standard Specification forRubber Surgical Gloves |
| Size | |||
| 6.0 (76+/-6mm) | 76mm | 74mm | Similar |
| 6.5 (83+/-6mm) | 84mm | 86mm | Meets ASTM D3577-2019,Standard Specification forRubberSurgical Gloves |
| 7.0 (89+/-6mm) | 90mm | 92mm | |
| 7.5 (95+/-6mm) | 96mm | 98mm | |
| 8.0 (102+/6mm) | 102mm | 105mm | |
| 8.5 (108+/6mm) | 109mm | 110mm | |
| 9.0 (114+/6mm) | 115mm | 116mm | |
| Cuff, Palm, Finger TipMin0.10 mm | Cuff- 0.16mmPalm-0.18mmFinger Tip-0.22mm | Cuff- 0.12mmPalm-0.16mmFinger Tip-0.21mm | |
| Tensile Strength24Mpa minimumBefore Aging | 37Mpa | 28.55Mpa | SimilarMeets ASTM D3577-2019,Standard Specification for |
| Ultimate Elongation750% minimumBefore Aging | 814% | 870% | Rubber Surgical Gloves |
| Stress at 500%5.5 MPa MaxBefore Aging | 3.5Mpa | 5.1Mpa | |
| Tensile Strength 18MpaminimumAfter Aging | 32.49Mpa | 23.48Mpa | SimilarMeets ASTM D3577-2019,Standard Specification forRubberSurgical Gloves |
| Ultimate Elongation560% minimum AfterAging | 760% | 731% |
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| Characteristics | Acceptance criteria of thestandard | Remarks | |
|---|---|---|---|
| Subject deviceK231446 | PredicatedeviceK212848 | ||
| Freedom fromHolesAQL 1.5 | AQL 1.5 | AQL 1.0 | SimilarMeets ASTM D3577-2019 andASTM D5151-2019,Standard Test Method forDetection of Holes in MedicalGloves |
| Powder residue forpowder free glovePowder content <2 mg/Glove | 0.21 mg/Glove | 0.40 mg/Glove | SimilarMeets ASTM D3577-2019 andASTMD6124-06,(Reapproved 2017),Standard Test Method forResidual Powder on MedicalGloves |
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| Characteristics | Biocompatibility | Acceptance criteria of the standard | Remarks | |
|---|---|---|---|---|
| Subject deviceK231446 | Predicate deviceK212848 | |||
| Skin Irritation &Skin Sensitization | ISO 10993-10,Biologicalevaluation of medicaldevices - Part 10:Tests for irritation andskinsensitization | Non- irritant andNon-Sensitizer | Non- irritant andNon-Sensitizer | Same |
| In vitro cytotoxicity | ISO 10993-5:2009(E),BiologicalEvaluation of MedicalDevices - Part 5-Testsforin vitro Cytotoxicity | Cytotoxic | Cytotoxic | Same |
| Material Mediatedpyrogenicity | ISO 10993-11:2017(E),Biological Evaluationof Medical Devices -Part 11, Tests forSystemic Toxicity andUSP 41<151>Pyrogen Test | Non pyrogenic | No data available | ----- |
| Acute SystemicToxicity | ISO 10993-11:2017(E),Biological Evaluationof Medical Devices -Part 11, Tests forSystemic Toxicity | Under theconditions ofstudy thedevice extractsdo not pose anacute systemictoxicityconcern | Under theconditions of studythedevice extracts donot pose an acutesystemic toxicityconcern | Same |
| BacterialEndotoxin | USP 42 <85> | <20EU/pair ofgloves | <20EU/pair ofgloves | Same |
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VII. Non-Clinical Testing
Non clinical tests were conducted in accordance with following standards to verify that the proposed device met all design specifications.
- · 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 D5712-15 Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method
- ASTM D7160-05 Standard Practice for Determination of Expiration Dating for medical Gloves
- 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
- ISO 10993-11:2017 Biological Evaluation of Medical Devices Part 5: Tests For systemic toxicity
- · ISO 11137-1-2006/ (R) 2010 validation of sterilization process
- · ISO 11137-2:2013, sterilization of health care products radiation part 2: Establishing the sterilization dose
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| TestMethodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D3577-19 | Physical Dimension | The actual measureddimension of thegloves shall meetthe statedtolerance specifiedin Table 2 of theASTM D3577-19 | Meets therequirement |
| ASTM D3577-19 | Determination ofPhysical Properties | Before and afterAccelerated aging,the gloves shallconform to thephysicalrequirements inTable 3 of ASTMD3578-19 | Meets therequirement |
| ASTM D5151-19 | Water Leak Test forDetection of Holes | The gloves shall befree from holewhen tested inaccordance withthe method givenin ASTM D5151 | Meets therequirement AQL1.5 |
| ASTM D6124-06(2017) | Residual PowderContent Test | The powder residuecontent shall benot more than2mg per gloves. | Meets therequirement |
| ASTM D5712-15 | Protein Content | <200µg/dm² | Meets therequirement |
| ISO 10993-10:2010 | Skin Sensitization | Non-sensitizing | Meets therequirement |
| ISO 10993-10:2010 | Skin irritation | Non-irritating | Meets therequirement |
| ISO 10993-11:2017 | Systemic toxicity | Non-systemic toxicity | Meets therequirement |
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VIII.Clinical Testing
No clinical study is included in this submission.
IX. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(K) submission, the Single-Use Latex Sterile Surgical Gloves is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K212848.
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K231446 Page 10 of 9
§ 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).