(187 days)
The Polyisoprene Surgical Gloves are sterile and single use device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination.
The proposed device is Polyisoprene Surgical Gloves, sterile and disposable devices. The proposed devices are made of polyisoprene. The proposed device is white. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D3577.
The provided document is a 510(k) summary for Polyisoprene Surgical Gloves, which are a Class I medical device. The document does not describe an AI/ML-enabled device or an diagnostic device requiring an MRMC study or AI-specific acceptance criteria.
The acceptance criteria provided in the document relate to the physical and biological characteristics of the surgical gloves as per various ASTM and ISO standards, and the "study" is a series of non-clinical performance tests confirming the gloves meet these established standards.
Therefore, I cannot extract information related to AI/ML device performance, sample sizes for test sets in an AI context, expert ground truth establishment, MRMC studies, or training set details as these are not relevant to the product described in the input.
However, I can extract the acceptance criteria and performance data for the Polyisoprene Surgical Gloves as presented in the document.
Acceptance Criteria and Reported Device Performance (for Polyisoprene Surgical Gloves)
1. Table of Acceptance Criteria and Reported Device Performance
| No. | Name of the Test Methodology / Standard | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|---|
| 1 | ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Skin Sensitization. | Assesses possible contact hazards released from medical devices, which may produce skin and mucosal irritation, eye irritation or skin sensitization. | Skin Sensitization Test: provided grades less than 1, otherwise sensitization. | All grades are 0. All animals were survived, and no abnormal signs were observed during the study. |
| 2 | ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation | Assesses possible contact hazards released from medical devices, which may produce skin and mucosal irritation, eye irritation or skin sensitization. | Skin Irritation Test: If the primary irritation index is 0-0.4, the response category is Negligible. 0.5-1.9 means slight, 2-4.9 means moderate, 5-8 means severe. | The primary irritation index is 0. The response of the proposed device was categorized as negligible under the test condition. |
| 3 | ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity | Describes test methods to assess the in vitro cytotoxicity of medical devices. | The viab.% of the 100% extract of the test article is the final result, and if viability is reduced to <70% of the blank, it has cytotoxic potential. | Viab.% of 100% test article extract is 6.1%. It means the proposed device have potential toxicity to L-929 in the MTT method. |
| 4 | ISO 10993-11: 2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity | To evaluate the potential for medical device materials to cause adverse systemic reactions. | Within the monitoring period (72 h), if the toxicosis response of testing group is not greater than that of control group, the testing sample is regarded as acceptable. | There was no evidence of systemic toxicity from the extract. |
| 5 | ISO 10993-7 standards for EO/ECH residual testing | Specifies allowable limits for residual ethylene oxide (EO). | Limit (< 24 h) EO 4 mg; ECH 9 mg. Prolonged (> 24 h < 30 d) EO 60 mg/30 d; ECH 60 mg/30 d. | EO residue: ≤ 4mg in the first 24h; ≤ 60mg in the first 30d; EO residue shall also ≤ 10ug/g; ECH residue: ≤ 9mg in the first 24h; ≤ 60mg in the first 30d. |
| 6 | ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves | Designed to determine the amount of residual powder (or filter-retained mass) found on medical gloves. | powder residue limit of 2.0 mg | 0.1mg/glove |
| 7 | ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves. 12/23/2019 | Covers the detection of holes in medical gloves. | Samples number: 200 gloves; AQL: 1.5 (ISO 2859); Criterion ≤7 gloves for water leakage. | 0 glove water leakage found |
| 8 | 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 | Intended to test NR, latex, and elastomeric materials for residual protein content. | Have a recommended aqueous soluble protein content limit of 200 ug/dm² | 52ug/dm² |
| 9 | ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | Intended as a reference to the performance and safety of rubber surgical gloves. | Dimensions: -6.5: width 83±6mm, Length ≥265 mm -7: width 89±6mm, Length ≥265 mm -7.5: width 95±6mm, Length ≥265 mm -8: width 102±6mm, Length ≥265 mm Thickness: -Finger ≥0.10 mm -Palm ≥0.10 mm -Cuff ≥0.10 mm Physical properties: ● Before aging ● Tensile strength ≥17MPa ● Ultimate Elongation ≥ 650% ● Stress at 500% Elongation ≤ 7.0 MPa ● After Accelerated Aging ● Tensile strength ≥12MPa ● Ultimate Elongation ≥ 490% | Dimensions: 6.5: width: 83-84 mm, Length 280-289 mm Thickness: Finger 0.230-0.260 mm, Palm 0.188-0.207 mm, Cuff 0.137-0.151 mm 7: width 91-93 mm, Length 271-278 mm Thickness: Finger 0.211-0.241 mm, Palm 0.181-0.193 mm, Cuff 0.133-0.144 mm 7.5: width 96-98 mm, Length 273-280 mm Thickness: Finger 0.218-0.237mm, Palm 0.180-0.192 mm, Cuff 0.136-0.146 mm 8: width 103-105 mm, Length 268-283 mm Thickness: Finger 0.221-0.272 mm, Palm 0.189-0.212 mm, Cuff 0.143-0.153 mm Physical properties: Before aging -Tensile strength 25.2-30.9 MPa -Ultimate Elongation 721% - 777% -Stress at 500% Elongation 6.5-7.0 MPa After Accelerated Aging -Tensile strength 23.0-29.0 MPa -Ultimate Elongation 680% - 716% |
2. Sample Size Used for the Test Set and Data Provenance:
- Holes in Medical Gloves (ASTM D5151-19): 200 gloves were sampled for this specific test.
- Other tests (Biological, Chemical, Physical property tests): The document does not specify a distinct "test set" sample size for each individual test beyond the 200 gloves for hole detection. Standard methodologies like ISO and ASTM usually define sample sizes for their respective tests, which are implicitly followed.
- Data Provenance: Not specified, but the applicant company is Puyang Linshi Medical Supplies Co., Ltd. in China, suggesting the testing was likely conducted in China or by labs cooperating with them. The document does not state if the data is retrospective or prospective; it describes non-clinical performance testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable. This device is surgical gloves, not a diagnostic device requiring expert interpretation for ground truth. Ground truth is established by physical and chemical test results against international standards.
4. Adjudication Method for the Test Set:
- Not applicable. This is not an image-based diagnostic or AI/ML device requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, this type of study is not applicable to surgical gloves. It is typically conducted for diagnostic devices (e.g., AI in radiology).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-based device.
7. The Type of Ground Truth Used:
- The ground truth is established by adherence to recognized international standards and test methodologies (e.g., ISO 10993 series for biological evaluation, ASTM D6124, D5151, D3577 for physical and chemical properties). This involves laboratory measurements and observations based on predefined criteria.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device, so 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 this device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 9, 2023
Puyang Linshi Medical Supplies Co., Ltd. % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room 608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K230304
Trade/Device Name: Polyisoprene Surgical Gloves Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO Dated: July 8, 2023 Received: July 11, 2023
Dear Boyle 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.
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 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,
Allan Guan -S
For 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230304
Device Name Polyisoprene Surgical Gloves
Indications for Use (Describe)
The Polyisoprene Surgical Gloves are sterile and single use device intended to be worn on the hands of 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 (K230304)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with 21 CFR 807.92.
1.0 submitter's information
Name: Puyang Linshi Medical Supplies Co., Ltd. Address: East of Panjin Road and North of Fumin Road in Puyang County, Puyang City, Henan Province 457001, China. Phone Number: +86-19839327898 Contact: Catherine Liu Date of Preparation: 08.01.2023
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device information
Trade name: Polyisoprene Surgical Gloves Common name: Surgeon's Gloves Classification name: Surgeon's Gloves Model(s): 6.5, 7, 7.5, 8
3.0 Classification
Production code: KGO Regulation number: 21CFR878.4460 Classification: Class I Panel: General Hospital
4.0 Predicate device information
Better Care Plastic Technology Co., Ltd. Manufacturer: Sterile Polyisoprene Powder Free Surgical Gloves Device: 510(k) number: K171047
5.0 Indications for use
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The Polyisoprene Surgical Gloves are sterile and single use device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination.
6.0 Device description
The proposed device is Polyisoprene Surgical Gloves, sterile and disposable devices. The proposed devices are made of polyisoprene. The proposed device is white. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D3577.
7.0 Summary comparing technological characteristics with predicate device
| Item | Proposed device | Predicated device | Remark |
|---|---|---|---|
| 510(k) number | K230304 | K171047 | |
| Product Code | KGO | KGO | Same |
| Regulation No. | 21CFR878.4460 | 21CFR878.4460 | Same |
| Class | I | I | Same |
| Indicationsfor Use | The Polyisoprene Surgical Gloves are sterile and single use device intended tobe worn on the hands ofoperating room personnel toprotect a surgical woundfrom contamination. | This surgeon's glove is a sterile and single use device intended tobe worn on the hands ofoperating room personnel toprotect a surgical wound fromcontamination. | Same |
| Prescription or OverThe Counter Use | Over-The-Counter-Use | Over-The-Counter-Use | Same |
| Materials | Synthetic polyisoprene rubber | Synthetic polyisoprene rubber | Same |
| Design | Single useSterilePowder-freeHand SpecificBeaded cuff | Single useSterilePowder-freeHand SpecificBeaded cuff | Same |
| Color | White | Clear | Difference 1 |
| Dimensions andphysical properties | Meets ASTM D3577- 2019 | Meets ASTM D3577-09 (2015) | Difference 2 |
| Sterilizationmethod | EO Sterilization | Radiation | Difference 3 |
| Sterility Assurance | 10-6 SAI | 10-6 SAI | Same |
Table1-General Comparison
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| Level (SAL) | |||
|---|---|---|---|
| Freedom fromholes | Meets ASTM D3577- 2019 Clause8.3 (ASTM D5151-19)Inspection level/AQL: GI/AQL 1.5 | Meets ASTM D3577- 09(2015)Inspection level/AQL: GI/AQL 1.5 | Difference 2 |
| Powder-Free | Meets ASTM D 6124-06 Theaveraged residual powder contentfor the glove during processvalidation is 0.1mg per glove | Meets ASTM D 6124-06 Theaveraged residual powdercontent for the gloveduring process validation is0.16mg per glove | Similar |
| Primary SkinIrritationISO 10993- 10:2010 | Under the conditions of thestudy (per ISO 10993-23), thedevice is not an irritant | Under the conditions of thestudy (per ISO 10993-10), thedevice is not an irritant | Difference 4 |
| DermalSensitization -ISO 10993-10:2010 | Under the conditions of thestudy (per ISO 10993-10), nota sensitizer | Under the conditions of thestudy (per ISO 10993-10), nota sensitizer | Same |
| Acute SystemicToxicity - ISO10993-11: 2006 | Under the conditions of the study,there was no mortality or evidenceof Acute systemictoxicity | Under the conditions of the study,there was no mortality orevidence of Acute systemictoxicity | Same |
| Shelf Life | 2 years | 3 years | Difference 5 |
Analysis:
Difference 1: The colors of proposed device are different with those of the predicate, but they all meet the requirements of ASTM D3577-19, so the differences do not raise any new safety or performance questions.
Difference 2: The proposed device and the predicate device meet different requirements ASTM D3577-19 and ASTM D3577-09 as the ASTM D3577-19 is the only Consensus Standard for Rubber Surgical Gloves Recognized by FDA, but the differences do not raise any new safety or performance questions.
Difference 3: The proposed device and the predicate device sterilized by different methods EO Sterilization and Radiation, but the EO validation of proposed device was implemented based on ISO 11135:2014, including sterilizer installation, OQ, PPQ and MPQ of sterilization. And parameters in Sterilization Validation Report can prove these products being SAL of 10-6.
Difference 4: New standard ISO10993-23:2021 replaces the Skin Irritation test in ISO10993-10:2010. Difference 5: The shelf life of proposed device is verified by Product Performance Test Report after 2 Years Accelerated Aging.
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8.0 Summary of Non-Clinical Performance Testing
The following performance data has been provided to demonstrate that the subject device meets the acceptance criteria in the standard.
| No. | Name of the TestMethodology / Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|
| 1 | ISO 10993-10:2010Biological Evaluation OfMedical Devices - Part10: Tests For SkinSensitization. | This part of ISO10993 assessespossible contacthazards releasedfrom medical devices, | Skin Sensitization Test:providedgrades less than 1,otherwise sensitization. | All grades are 0.All animals were survived, and no abnormal signs were observed during the study. |
| 2 | ISO 10993-23:2021Biological evaluation ofmedical devices - Part23: Tests for irritation | which may produceskin and mucosalirritation, eye irritationor skin sensitization. | Skin Irritation Test:If the primary irritationindex is 0-0,4, theresponse category isNegligible.0,5-1,9 means slight2-4,9 means moderate5-8 means severe | The primary irritation index is 0.The response of the proposed device was categorized as negligible under the test condition |
| 3 | ISO 10993-5:2009Biological Evaluation OfMedical Devices - Part5: Tests For In VitroCytotoxicity | This part of ISO10993 describes testmethods to assessthe in vitro cytotoxicityof medical devices. | The viab.% of the 100%extract of the test articleis the final result, and ifviability is reduced to<70% of the blank, ithas cytotoxic potential. | Viab.% of 100% test articleextract is 6.1%It means the proposeddevice have potential toxicityto L-929 in the MTT method |
| 4 | ISO 10993-11: 2017Biological evaluation ofmedical devices — Part11: Tests for systemictoxicity | To evaluate thepotential for medicaldevice materials tocause adversesystemic reactions. | Within the monitoringperiod (72 h), if thetoxicosis response oftesting group is notgreater than that ofcontrol group, thetesting sample isregarded as acceptable. | There was no evidence ofsystemic toxicity from theextract. |
| 5 | ISO 10993-7 standardsfor EO/ECH residualtesting | This part of ISO10993 specifiesallowable limits forresidual ethyleneoxide (EO) | Limit(< 24 h) EO 4 mgECH 9 mgProlonged(> 24 h < 30 d) EO 60mg/30 dECH 60 mg/30 d | EO residue: ≤ 4mg inthe first 24h; ≤ 60mg inthe first 30d; EOresidue shall also ≤10ug/g;ECH residue: ≤ 9mg inthe first 24h; ≤ 60mg inthe first 30d. |
| 6 | ASTM D6124-06(Reapproved 2017),Standard Test Methodfor Residual Powder onMedical Gloves | This standard isdesigned todetermine the amountof residual powder (orfilter-retained mass)foundon medical gloves | powder residue limit of2.0 mg | 0.1mg/glove |
| 7 | ASTMD5151-19, Standard TestMethod for Detection ofHoles in Medical Gloves.12/23/2019 | This test methodcovers the detectionof holes inmedical gloves. | Samples number: 200glovesAQL: 1.5 (ISO 2859)Criterion ≤7 gloves forwater leakage | 0 glove water leakage found |
| 8 | ASTM D5712-15Standard Test Methodfor Analysis of AqueousExtractable Protein inNatural Rubber in Latex,Natural Rubber, andElastomeric ProductsUsing the ModifiedLowry Method | This test method, forthe determination ofprotein levelsin latex, is primarilyintended to test NR,latex, and elastomericmaterials for residualprotein content. | Have a recommendedaqueous soluble proteincontent limit of 200ug/dm² | 52ug/dm² |
| 9 | ASTMD3577-19, StandardSpecification for RubberSurgical Gloves | The specification isintended as areference to theperformance andsafety of rubbersurgical gloves. Thesafe and proper useof rubber surgicalgloves is beyond thescope of thisspecification. | Dimensions:-6.5: width 83±6mmLength ≥265 mm-7: width 89±6mmLength ≥265 mm-7.5: width 95±6mmLength ≥265 mm-8: width 102±6mmLength ≥265 mmThickness:-Finger ≥0.10 mm-Palm ≥0.10 mm-Cuff ≥0.10 mmPhysical properties:● Before aging● Tensile strength≥17MPa● Ultimate● Elongation ≥650%● Stress at 500%Elongation ≤ 7.0MPa● After AcceleratedAging● Tensile strength≥12MPa● Ultimate Elongation≥ 490% | Dimensions:6.5: width: 83-84 mmLength 280-289 mmThickness:Finger 0.230-0.260 mmPalm 0.188-0.207 mmCuff 0.137-0.151 mm7: width 91-93 mmLength 271-278 mmThickness:Finger 0.211-0.241 mmPalm 0.181-0.193 mmCuff 0.133-0.144 mm7.5: width 96-98 mmLength 273-280 mmThickness:Finger 0.218-0.237mmPalm 0.180-0.192 mmCuff 0.136-0.146 mm8: width 103-105 mmLength 268-283 mmThickness:Finger 0.221-0.272 mmPalm 0.189-0.212 mmCuff 0.143-0.153 mmPhysical properties: Beforeaging-Tensile strength 25.2-30.9MPa-Ultimate Elongation 721% -777%-Stress at 500% Elongation6.5-7.0 MPaAfter Accelerated Aging-Tensile strength 23.0-29.0MPa-Ultimate Elongation 680% -716% |
Table 2 Summary of Non-Clinical Performance Testing
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9. Summarv of Clinical Performance Test
No clinical study is included in this submission.
10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
§ 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).