Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves

K203483 · Guilin Hbm Health Protections, Inc. · KGO · Feb 1, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K203483
• Device Name: Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves
• Applicant: Guilin Hbm Health Protections, Inc.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Feb 1, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

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.

Device Story

Sterile, single-use surgical gloves; available in natural rubber or synthetic polyisoprene; powder-free; seven sizes; smooth or textured surface; optional rolled rim. Used by operating room personnel to provide a barrier against contamination of surgical wounds. Sterilized via ionizing irradiation. Shelf-life of three years. Performance verified through bench testing against ASTM standards for dimensions, physical properties, and barrier integrity.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Materials: Natural rubber or synthetic polyisoprene. Dimensions: 7 sizes (6"-9"). Sterilization: Ionizing irradiation. Standards: ASTM D3577-19, ASTM D3767-03(2020), ASTM D5151-19, ASTM D6124-06(2017), ASTM D412-16, ISO 10993 series, ISO 11137 series. Connectivity: None. Software: None.

Indications for Use

Indicated for use by operating room personnel to protect surgical wounds from contamination. Suitable for sterile, single-use applications.

Regulatory Classification

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.

Predicate Devices

• Sterile Polyisoprene Powder Free Surgical Gloves (K171047)
• JR Medic Latex Surgeon's Gloves Sterile Powder Free (K192328)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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

1) Medispo Rubber Surgical Gloves

2) 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.: [phone] E-mail: [e-mail]

Preparation date: Jan. 11, 2021

## II. Proposed Device

| Device Trade Name | 1) Medispo Rubber Surgical Gloves<br>2) 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<br>(K203483) | Predicate device<br>(K192328) | Discussion |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product name | Medispo Rubber Surgical<br>Gloves | JR Medic Latex Surgeon's<br>Gloves 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 |
| Gloves<br>classification | Type I, Surgeon's gloves | Type I, Surgeon's gloves | Same |
| Powder free | Yes | Yes | Same |
| Indication for<br>use | The surgical gloves are<br>sterile and single use device<br>intended to be worn on the<br>hands of operating room<br>personnel to protect a<br>surgical wound from<br>contamination. | A latex surgeon's glove is a<br>device made of natural<br>rubber intended to be worn<br>by operating room personnel<br>to protect a surgical wound<br>from contamination. | Same |
| Main Material | Natural rubber | Natural rubber | Same |
| Color | Creamy white | Creamy white | Same |
| Palm width | 6.0 (76mm±5mm)<br>6.5 (83mm±5mm)<br>7.0 (89mm±5mm) | 6.0 (78mm)<br>6.5 (85mm)<br>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)<br>6.5 (265mm min)<br>7.0 (270mm min)<br>7.5 (270mm min)<br>8.0 (270mm min)<br>8.5 (280mm min)<br>9 (280mm min) | 300 mm | Different |
| Thickness | Cuff: min 0.10mm<br>Palm: min 0.13mm<br>Finger tip: min 0.13mm | Cuff: 0.11mm<br>Palm: 0.18mm<br>Finger tip: 0.21mm | Similar |
| Freedom from<br>holes | Meets requirements of the<br>ASTM D3577-19 | Meets requirements of the<br>ASTM D3577-09(2015) | Similar |
| Physical<br>Properties<br>(before aging) | Meets requirements of the<br>ASTM D3577-19 | Meets requirements of the<br>ASTM D3577-09(2015) | Similar |
| Physical<br>Properties<br>(after aging) | Meets requirements of the<br>ASTM D3577-19 | Meets requirements of the<br>ASTM D3577-09(2015) | Similar |
| Powder<br>residual | ≤2.0 mg/glove | ≤2.0 mg/glove | Same |
| Special label<br>claim | No protein labeling statement | Protein content label claim of<br>50µg/dm² or less | Different |
| Sterility | Sterile | Sterile | Same |
| Sterilization<br>method | 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 requirements<br>of ISO 10993 series<br>standards | Conform to the requirements<br>of ISO 10993 series<br>standards | Same |
| Table 2 Comparison of Polyisoprene Surgical Gloves | | | |
| Item | Proposed device<br>(K203483) | Predicate device<br>(K171047) | Discussion |
| Product name | Medispo Polyisoprene<br>Surgical Gloves | Sterile Polyisoprene Powder<br>Free Surgical Gloves | - |
| Product Code | KGO | KGO | Same |
| Regulation No. | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Classification | Class I | Class I | Same |
| Gloves<br>classification | Type II, Surgeon's gloves | Type II, Surgeon's gloves | Same |
| Powder free | Yes | Yes | Same |
| Indication for<br>use | The surgical gloves are<br>sterile and single use device<br>intended to be worn on the<br>hands of operating room<br>personnel to protect a<br>surgical wound from<br>contamination. | A latex surgeon's glove is a<br>device made of natural<br>rubber intended to be worn<br>by operating room personnel<br>to protect a surgical wound<br>from contamination. | Same |
| Main Material | Synthetic Polyisoprene | Synthetic Polyisoprene | Same |
| Color | Creamy white | Creamy white | Same |
| Palm width | 6.0 (76mm±5mm)<br>6.5 (83mm±5mm)<br>7.0 (89mm±5mm)<br>7.5 (95mm±5mm)<br>8.0 (102mm±6mm)<br>8.5 (108 mm±6mm<br>9 (114mm±6mm) | 5.5 (70mm)<br>6.0 (76mm)<br>6.5 (83mm)<br>7.0 (89mm)<br>7.5 (95mm)<br>8.0 (102mm)<br>8.5 (108mm)<br>9 (114mm) | Similar |
| Length | 6.0 (265mm min)<br>6.5 (265mm min)<br>7.0 (270mm min)<br>7.5 (270mm min)<br>8.0 (270mm min)<br>8.5 (280mm min)<br>9 (280mm min) | Minimum 265<br>Average 305 mm | Similar |
| Thickness | Cuff: 0.10mm min<br>Palm: 0.13mm min<br>Finger tip: 0.13mm min | Cuff: 0.10mm min<br>Palm: 0.10mm min<br>Finger tip : 0.10mm min | Similar |
| Freedom from | Meets requirements of the | Meets requirements of the | Similar |
| | | | |
| holes | ASTM D3577-19 | ASTM D3577-09(2015) | |
| Physical<br>Properties<br>(before aging) | Meets requirements of the<br>ASTM D3577-19 | Meets requirements of the<br>ASTM D3577-09(2015) | Similar |
| Physical<br>Properties<br>(after aging) | Meets requirements of the<br>ASTM D3577-19 | Meets requirements of the<br>ASTM D3577-09(2015) | Similar |
| Powder<br>residual | ≤2.0 mg/glove | ≤2.0 mg/glove | Same |
| Sterility | Sterile | Sterile | Same |
| Sterilization<br>method | 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 requirements<br>of ISO 10993 series<br>standards | Conform to the requirements<br>of ISO 10993 series<br>standards | 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 /<br>Standard | Acceptance Criteria | Results |
|------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------|---------|
| Palm width | ASTM D3767-03(2020) | 6.0 (76mm±5mm)<br>6.5 (83mm±5mm)<br>7.0 (89mm±5mm)<br>7.5 (95mm±5mm)<br>8.0 (102mm±6mm)<br>8.5 (108 mm±6mm)<br>9 (114mm±6mm) | Pass |

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| Length | ASTM D3767-03(2020) | 6.0 (265mm min)<br>6.5 (265mm min)<br>7.0 (270mm min)<br>7.5 (270mm min)<br>8.0 (270mm min)<br>8.5 (280mm min)<br>9 (280mm min) | Pass |
|---------------------------------------|---------------------|---------------------------------------------------------------------------------------------------------------------------------|------|
| Thickness | ASTM D3767-03(2020) | Cuff: min 0.10mm<br>Palm: min 0.13mm<br>Finger tip: min 0.13mm | Pass |
| Freedom<br>from holes | ASTM D5151-19 | Freedom free hole AQL<br>1.5 | Pass |
| Physical Properties<br>(before aging) | | | |
| Tensile<br>Strength | ASTM D412-16 | ≥24 MPa | Pass |
| Ultimate<br>Elongation | ASTM D412-16 | ≥750% | Pass |
| Physical Properties<br>(after aging) | | | |
| Tensile<br>Strength | ASTM D412-16 | ≥18 MPa | Pass |
| Ultimate<br>Elongation | ASTM D412-16 | ≥560% | Pass |
| Powder<br>residual | 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.