(66 days)
The Medispo Rubber/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 devices, surgical gloves, are sterile and disposable devices. There are two types of surgical gloves according to the raw materials in this submission:
- Type 1-Natural rubber surgical gloves .
- Type 2-Synthetic polyisoprene surgical gloves .
The proposed devices are powder-free gloves with creamy white in color. There are seven sizes (6", 6.5", 7", 7.5", 8", 8.5", 9") available for the gloves whichever are smooth- or texture-surfaced, with or without a rolled rim at the cuff edge.
The gloves are sterilized by ionizing irradiation. The shelf-life is three (3) years.
This document is a 510(k) premarket notification for Medispo Rubber Surgical Gloves and Medispo Polyisoprene Surgical Gloves. It compares the proposed devices to legally marketed predicate devices to demonstrate substantial equivalence.
Here's a breakdown of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Acceptance Criteria (Methodology / Standard) | Reported Device Performance |
|---|---|---|
| Medispo Rubber Surgical Gloves (Main Material: Natural Rubber) | ||
| Product Code | KGO | KGO |
| Regulation No. | 21 CFR 878.4460 | 21 CFR 878.4460 |
| Classification | Class I | Class I |
| Gloves classification | Type I, Surgeon's gloves | Type I, Surgeon's gloves |
| Powder free | Yes | Yes |
| Indication for use | To protect a surgical wound from contamination | To protect a surgical wound from contamination |
| Palm width | 76mm±5mm (6.0), 83mm±5mm (6.5), 89mm±5mm (7.0), 95mm±5mm (7.5), 102mm±6mm (8.0), 108mm±6mm (8.5), 114mm±6mm (9) (ASTM D3767-03(2020)) | Pass |
| Length | 265mm min (6.0, 6.5), 270mm min (7.0, 7.5, 8.0), 280mm min (8.5, 9) (ASTM D3767-03(2020)) | Pass |
| Thickness | Cuff: min 0.10mm, Palm: min 0.13mm, Finger tip: min 0.13mm (ASTM D3767-03(2020)) | Pass |
| Freedom from holes | AQL 1.5 (ASTM D5151-19) | Pass |
| Physical Properties (before aging) | Tensile Strength: ≥24 MPa, Ultimate Elongation: ≥750% (ASTM D412-16) | Pass |
| Physical Properties (after aging) | Tensile Strength: ≥18 MPa, Ultimate Elongation: ≥560% (ASTM D412-16) | Pass |
| Powder residual | ≤2.0 mg/glove (ASTM D6124-06(2017)) | Pass |
| Special label claim | No protein labeling statement | No protein labeling statement |
| Sterility | Sterile | Sterile |
| Sterilization method | Radiation | Radiation |
| For single use | Yes | Yes |
| Type of use | Over the counter use | Over the counter use |
| Biocompatibility | Conform to ISO 10993 series standards | Conform to ISO 10993 series standards |
| Medispo Polyisoprene Surgical Gloves (Main Material: Synthetic Polyisoprene) | ||
| Product Code | KGO | KGO |
| Regulation No. | 21 CFR 878.4460 | 21 CFR 878.4460 |
| Classification | Class I | Class I |
| Gloves classification | Type II, Surgeon's gloves | Type II, Surgeon's gloves |
| Powder free | Yes | Yes |
| Indication for use | To protect a surgical wound from contamination | To protect a surgical wound from contamination |
| Palm width | 76mm±5mm (6.0), 83mm±5mm (6.5), 89mm±5mm (7.0), 95mm±5mm (7.5), 102mm±6mm (8.0), 108mm±6mm (8.5), 114mm±6mm (9) (ASTM D3767-03(2020)) | Pass |
| Length | 265mm min (6.0, 6.5), 270mm min (7.0, 7.5, 8.0), 280mm min (8.5, 9) (ASTM D3767-03(2020)) | Pass |
| Thickness | Cuff: min 0.10mm, Palm: min 0.13mm, Finger tip: min 0.13mm (ASTM D3767-03(2020)) | Pass |
| Freedom from holes | AQL 1.5 (ASTM D5151-19) | Pass |
| Physical Properties (before aging) | Tensile Strength: ≥24 MPa, Ultimate Elongation: ≥750% (ASTM D412-16) | Pass |
| Physical Properties (after aging) | Tensile Strength: ≥18 MPa, Ultimate Elongation: ≥560% (ASTM D412-16) | Pass |
| Powder residual | ≤2.0 mg/glove (ASTM D6124-06(2017)) | Pass |
| Sterility | Sterile | Sterile |
| Sterilization method | Radiation | Radiation |
| For single use | Yes | Yes |
| Type of use | Over the counter use | Over the counter use |
| Biocompatibility | Conform to ISO 10993 series standards | Conform to ISO 10993 series standards |
Study that Proves the Device Meets Acceptance Criteria:
The document states: "The performance test of the subject devices were performed on the final finished device. The test results show the subject devices meet the requirements of ASTM D3577-19."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for each specific test or the data provenance (country of origin, retrospective/prospective). It only mentions that "performance tests...were performed on the final finished device" according to relevant ASTM and ISO standards.
3. 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)
This information is not applicable as the device is a surgical glove, and the evaluation is based on mechanical, physical, and chemical properties, as well as biocompatibility, against established standards. There is no "ground truth" requiring expert consensus in the context of medical image analysis or similar diagnostic applications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the type of device and testing performed. Adjudication methods are typically relevant for subjective evaluations or interpretations, which are not present here.
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
This information is not applicable as the device is a surgical glove and does not involve human readers or AI assistance in its function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance evaluation of the surgical gloves is based on established industry and regulatory standards such as ASTM D3577-19, ASTM D3767-03(2020), ASTM D5151-19, ASTM D6124-06(2017), ASTM D412-16, relevant USP standards, and ISO 10993 series standards for biocompatibility. These standards define the acceptable physical, mechanical, and biological properties of the gloves.
8. The sample size for the training set
This information is not applicable as the device is a physical product (surgical gloves) and does not involve machine learning models that require training sets.
9. How the ground truth for the training set was established
This information is not applicable as the device is a physical product and does not involve machine learning models that require training sets or their associated ground truth.
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Image /page/0/Picture/2 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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
February 1, 2021
Guilin HBM Health Protections, Inc. % Shelley Li Director Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 703, 705, Baohua International Plaza, West Guangzhong Road 555, Jingan Shanghai, 200071 China
Re: K203483
Trade/Device Name: Medispo Rubber Surgical Gloves, Medispo 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: November 19, 2020 Received: November 27, 2020
Dear Shelley Li:
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,
For: Elizabeth F. Claverie-Williams, MS 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) K203483
Device Name
-
Medispo Rubber Surgical Gloves
-
Medispo Polyisoprene Surgical Gloves
Indications for Use (Describe)
The Medispo Rubber/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: K203483
l. Submitter
Guilin HBM Health Protections, Inc. No.1-2, Shuijing East Road, Economic and Technological Development Area, Guilin, China
Contact person: Pu Lei Position: QC Manager Tel.: +86-13707738532 E-mail: pulei@hbmchina.com
Preparation date: Jan. 11, 2021
II. Proposed Device
| Device Trade Name | 1) Medispo Rubber Surgical Gloves2) Medispo Polyisoprene Surgical Gloves |
|---|---|
| Common name: | Surgeon's gloves |
| Regulation Number: | 21 CFR 878.4460 |
| Regulatory Class: | Class I |
| Product code: | KGO |
| Review Panel | General Hospital |
III. Predicate Devices
| a. 510(k) Number: | K171047 |
|---|---|
| Trade name: | Sterile Polyisoprene Powder Free Surgical Gloves |
| Common name: | Surgeon's Gloves |
| Classification: | Class I |
| Product Code: | KGO |
| Manufacturer | Better Care Plastic Technology Co., Ltd. |
| b. 510(k) Number: | K192328 |
| Trade name: | JR Medic Latex Surgeon's Gloves Sterile Powder Free |
| Common name: | Surgeon's Gloves |
| Classification: | Class I |
| Product Code: | KGO |
| Manufacturer | JR Engineering & Medical Technologies (M) SDN.BHD. |
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IV. Device description
The proposed devices, surgical gloves, are sterile and disposable devices. There are two types of surgical gloves according to the raw materials in this submission:
- Type 1-Natural rubber surgical gloves .
- Type 2-Synthetic polyisoprene surgical gloves .
The proposed devices are powder-free gloves with creamy white in color. There are seven sizes (6", 6.5", 7", 7.5", 8", 8.5", 9") available for the gloves whichever are smooth- or texture-surfaced, with or without a rolled rim at the cuff edge.
The gloves are sterilized by ionizing irradiation. The shelf-life is three (3) years.
V. Indication for use
The 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.
| Item | Proposed device(K203483) | Predicate device(K192328) | Discussion |
|---|---|---|---|
| Product name | Medispo Rubber SurgicalGloves | JR Medic Latex Surgeon'sGloves Sterile Powder Free | - |
| Product Code | KGO | KGO | Same |
| Regulation No. | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Classification | Class I | Class I | Same |
| Glovesclassification | Type I, Surgeon's gloves | Type I, Surgeon's gloves | Same |
| Powder free | Yes | Yes | Same |
| Indication foruse | The surgical gloves aresterile and single use deviceintended to be worn on thehands of operating roompersonnel to protect asurgical wound fromcontamination. | A latex surgeon's glove is adevice made of naturalrubber intended to be wornby operating room personnelto protect a surgical woundfrom contamination. | Same |
| Main Material | Natural rubber | Natural rubber | Same |
| Color | Creamy white | Creamy white | Same |
| Palm width | 6.0 (76mm±5mm)6.5 (83mm±5mm)7.0 (89mm±5mm) | 6.0 (78mm)6.5 (85mm)7.0 (88mm) | Similar |
| 7.5 (95mm±5mm) | 7.5 (97mm) | ||
| 8.0 (102mm±6mm) | 8.0 (103mm) | ||
| 8.5 (108 mm±6mm) | 8.5 (110mm) | ||
| 9 (114mm±6mm) | 9(116mm) | ||
| Length | 6.0 (265mm min)6.5 (265mm min)7.0 (270mm min)7.5 (270mm min)8.0 (270mm min)8.5 (280mm min)9 (280mm min) | 300 mm | Different |
| Thickness | Cuff: min 0.10mmPalm: min 0.13mmFinger tip: min 0.13mm | Cuff: 0.11mmPalm: 0.18mmFinger tip: 0.21mm | Similar |
| Freedom fromholes | Meets requirements of theASTM D3577-19 | Meets requirements of theASTM D3577-09(2015) | Similar |
| PhysicalProperties(before aging) | Meets requirements of theASTM D3577-19 | Meets requirements of theASTM D3577-09(2015) | Similar |
| PhysicalProperties(after aging) | Meets requirements of theASTM D3577-19 | Meets requirements of theASTM D3577-09(2015) | Similar |
| Powderresidual | ≤2.0 mg/glove | ≤2.0 mg/glove | Same |
| Special labelclaim | No protein labeling statement | Protein content label claim of50µg/dm² or less | Different |
| Sterility | Sterile | Sterile | Same |
| Sterilizationmethod | Radiation | Radiation | Same |
| For single use | Yes | Yes | Same |
| Type of use | Over the counter use | Over the counter use | Same |
| Biocompatibility | Conform to the requirementsof ISO 10993 seriesstandards | Conform to the requirementsof ISO 10993 seriesstandards | Same |
| Table 2 Comparison of Polyisoprene Surgical Gloves | |||
| Item | Proposed device(K203483) | Predicate device(K171047) | Discussion |
| Product name | Medispo PolyisopreneSurgical Gloves | Sterile Polyisoprene PowderFree Surgical Gloves | - |
| Product Code | KGO | KGO | Same |
| Regulation No. | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Classification | Class I | Class I | Same |
| Glovesclassification | Type II, Surgeon's gloves | Type II, Surgeon's gloves | Same |
| Powder free | Yes | Yes | Same |
| Indication foruse | The surgical gloves aresterile and single use deviceintended to be worn on thehands of operating roompersonnel to protect asurgical wound fromcontamination. | A latex surgeon's glove is adevice made of naturalrubber intended to be wornby operating room personnelto protect a surgical woundfrom contamination. | Same |
| Main Material | Synthetic Polyisoprene | Synthetic Polyisoprene | Same |
| Color | Creamy white | Creamy white | Same |
| Palm width | 6.0 (76mm±5mm)6.5 (83mm±5mm)7.0 (89mm±5mm)7.5 (95mm±5mm)8.0 (102mm±6mm)8.5 (108 mm±6mm9 (114mm±6mm) | 5.5 (70mm)6.0 (76mm)6.5 (83mm)7.0 (89mm)7.5 (95mm)8.0 (102mm)8.5 (108mm)9 (114mm) | Similar |
| Length | 6.0 (265mm min)6.5 (265mm min)7.0 (270mm min)7.5 (270mm min)8.0 (270mm min)8.5 (280mm min)9 (280mm min) | Minimum 265Average 305 mm | Similar |
| Thickness | Cuff: 0.10mm minPalm: 0.13mm minFinger tip: 0.13mm min | Cuff: 0.10mm minPalm: 0.10mm minFinger tip : 0.10mm min | Similar |
| Freedom from | Meets requirements of the | Meets requirements of the | Similar |
| holes | ASTM D3577-19 | ASTM D3577-09(2015) | |
| PhysicalProperties(before aging) | Meets requirements of theASTM D3577-19 | Meets requirements of theASTM D3577-09(2015) | Similar |
| PhysicalProperties(after aging) | Meets requirements of theASTM D3577-19 | Meets requirements of theASTM D3577-09(2015) | Similar |
| Powderresidual | ≤2.0 mg/glove | ≤2.0 mg/glove | Same |
| Sterility | Sterile | Sterile | Same |
| Sterilizationmethod | Radiation | Radiation | Same |
| For single use | Yes | Yes | Same |
| Type of use | Over the counter use | Over the counter use | Same |
| Biocompatibility | Conform to the requirementsof ISO 10993 seriesstandards | Conform to the requirementsof ISO 10993 seriesstandards | Same |
VI. Comparison of technological characteristics with the predicate devices Table 1 Comparison of Natural Rubber Surgical Gloves
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The performance test of the subject devices were performed on the final finished device. The test results show the subject devices meet the requirements of ASTM D3577-19.
VII. Summary of Non-Clinical Testing
Non-clinical performance tests were conducted in accordance with relevant standards to verify that the proposed device met all design specifications.
| Items | Methodology /Standard | Acceptance Criteria | Results |
|---|---|---|---|
| Palm width | ASTM D3767-03(2020) | 6.0 (76mm±5mm)6.5 (83mm±5mm)7.0 (89mm±5mm)7.5 (95mm±5mm)8.0 (102mm±6mm)8.5 (108 mm±6mm)9 (114mm±6mm) | Pass |
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| Length | ASTM D3767-03(2020) | 6.0 (265mm min)6.5 (265mm min)7.0 (270mm min)7.5 (270mm min)8.0 (270mm min)8.5 (280mm min)9 (280mm min) | Pass |
|---|---|---|---|
| Thickness | ASTM D3767-03(2020) | Cuff: min 0.10mmPalm: min 0.13mmFinger tip: min 0.13mm | Pass |
| Freedomfrom holes | ASTM D5151-19 | Freedom free hole AQL1.5 | Pass |
| Physical Properties(before aging) | |||
| TensileStrength | ASTM D412-16 | ≥24 MPa | Pass |
| UltimateElongation | ASTM D412-16 | ≥750% | Pass |
| Physical Properties(after aging) | |||
| TensileStrength | ASTM D412-16 | ≥18 MPa | Pass |
| UltimateElongation | ASTM D412-16 | ≥560% | Pass |
| Powderresidual | ASTM D6124-06(2017) | 2mg per glove | Pass |
The relevant standards used in the submission are listed as below:
- ASTM D3577-19, Standard Specification for Rubber Surgical Gloves .
- ASTM D3767-03(2020), Practice for rubber-Measurement of Dimensions .
- ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves ●
- ASTM D6124-06(2017), Standard Test Method for Residual Powder on Medical . Gloves
- . ASTM D5712-15, Standard Test Method for The Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method
- ASTM D573-04(2019), Standard Test Method for Rubber—Deterioration in an Air . Oven
- ASTM D412-16, Standard Test Methods for Vulcanized Rubber and . Thermoplastic Elastomers-Tension
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- USP 42/NF37 <151> Pyrogen Test ●
- USP 36_NF 31<71>Sterility Test ●
- ISO 11137-1:2006, Sterilization of health care products Radiation Part 1: ● Requirements for development, validation and routine control of a sterilization process for medical devices
- ISO 11137-2:2013, Sterilization of health care products -- Radiation -- Part 2: . Establishing the sterilization dose
- ISO 10993-5: 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, Biocompatibility Evaluation of Medical Device Part 11: Tests . for systemic toxicity
- ISO 10993-4:2017. Biological evaluation of medical devices-Part 4: Selection of . tests for interactions with blood
- ASTM F756-17 Standard Practice for assessments of hemolytic properties of ● material
VIII. Clinical Testing
No clinical study is included in this submission.
IX. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject 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).