Polyisoprene Surgical Gloves

K230304 · Puyang Linshi Medical Supplies Co., Ltd. · KGO · Aug 9, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K230304
• Device Name: Polyisoprene Surgical Gloves
• Applicant: Puyang Linshi Medical Supplies Co., Ltd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Aug 9, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

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.

Device Story

Polyisoprene surgical gloves; sterile, single-use, powder-free, hand-specific, beaded cuff design. Used by operating room personnel to provide a protective barrier between the wearer's hands and a surgical wound. Device acts as a physical barrier to prevent contamination. No electronic, software, or algorithmic components. Device is a passive medical supply.

Clinical Evidence

No clinical data. Bench testing only, including biocompatibility (ISO 10993-5, -7, -10, -11, -23), residual powder (ASTM D6124), hole detection (ASTM D5151), protein content (ASTM D5712), and physical properties/dimensions (ASTM D3577-19).

Technological Characteristics

Material: Synthetic polyisoprene rubber. Design: Sterile, powder-free, hand-specific, beaded cuff. Dimensions and physical properties meet ASTM D3577-19. Sterilization: Ethylene Oxide (EO) per ISO 11135:2014. SAL 10^-6.

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)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: [phone] Contact: Catherine Liu Date of Preparation: 08.01.2023

# Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Tel: [phone] Email: [e-mail]

# 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 |
| Indications<br>for Use | The Polyisoprene Surgical Gloves are sterile and single use device intended to<br>be worn on the hands of<br>operating room personnel to<br>protect a surgical wound<br>from contamination. | This surgeon's glove is a sterile and single use device intended to<br>be worn on the hands of<br>operating room personnel to<br>protect a surgical wound from<br>contamination. | Same |
| Prescription or Over<br>The Counter Use | Over-The-Counter-Use | Over-The-Counter-Use | Same |
| Materials | Synthetic polyisoprene rubber | Synthetic polyisoprene rubber | Same |
| Design | Single use<br>Sterile<br>Powder-free<br>Hand Specific<br>Beaded cuff | Single use<br>Sterile<br>Powder-free<br>Hand Specific<br>Beaded cuff | Same |
| Color | White | Clear | Difference 1 |
| Dimensions and<br>physical properties | Meets ASTM D3577- 2019 | Meets ASTM D3577-09 (2015) | Difference 2 |
| Sterilization<br>method | EO Sterilization | Radiation | Difference 3 |
| Sterility Assurance | 10-6 SAI | 10-6 SAI | Same |

#### Table1-General Comparison

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| Level (SAL) | | | |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|--------------|
| Freedom from<br>holes | Meets ASTM D3577- 2019 Clause<br>8.3 (ASTM D5151-19)<br>Inspection level/AQL: GI/AQL 1.5 | Meets ASTM D3577- 09(2015)<br>Inspection level/AQL: GI/AQL 1.5 | Difference 2 |
| Powder-Free | Meets ASTM D 6124-06 The<br>averaged residual powder content<br>for the glove during process<br>validation is 0.1mg per glove | Meets ASTM D 6124-06 The<br>averaged residual powder<br>content for the glove<br>during process validation is<br>0.16mg per glove | Similar |
| Primary Skin<br>Irritation<br>ISO 10993- 10:2010 | Under the conditions of the<br>study (per ISO 10993-23), the<br>device is not an irritant | Under the conditions of the<br>study (per ISO 10993-10), the<br>device is not an irritant | Difference 4 |
| Dermal<br>Sensitization -<br>ISO 10993-10:2010 | Under the conditions of the<br>study (per ISO 10993-10), not<br>a sensitizer | Under the conditions of the<br>study (per ISO 10993-10), not<br>a sensitizer | Same |
| Acute Systemic<br>Toxicity - ISO<br>10993-11: 2006 | Under the conditions of the study,<br>there was no mortality or evidence<br>of Acute systemic<br>toxicity | Under the conditions of the study,<br>there was no mortality or<br>evidence of Acute systemic<br>toxicity | 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 Test<br>Methodology / Standard | Purpose | Acceptance Criteria | Results |
|-----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | ISO 10993-10:2010<br>Biological Evaluation Of<br>Medical Devices - Part<br>10: Tests For Skin<br>Sensitization. | This part of ISO<br>10993 assesses<br>possible contact<br>hazards released<br>from medical devices, | Skin Sensitization Test:<br>provided<br>grades less than 1,<br>otherwise sensitization. | All grades are 0.<br><br>All animals were survived, and no abnormal signs were observed during the study. |
| 2 | ISO 10993-23:2021<br>Biological evaluation of<br>medical devices - Part<br>23: Tests for irritation | which may produce<br>skin and mucosal<br>irritation, eye irritation<br>or skin sensitization. | Skin Irritation Test:<br>If the primary irritation<br>index is 0-0,4, the<br>response category is<br>Negligible.<br>0,5-1,9 means slight<br>2-4,9 means moderate<br>5-8 means severe | The primary irritation index is 0.<br><br>The response of the proposed device was categorized as negligible under the test condition |
| 3 | ISO 10993-5:2009<br>Biological Evaluation Of<br>Medical Devices - Part<br>5: Tests For In Vitro<br>Cytotoxicity | This part of ISO<br>10993 describes test<br>methods to assess<br>the in vitro cytotoxicity<br>of medical devices. | The viab.% of the 100%<br>extract of the test article<br>is the final result, and if<br>viability is reduced to<br><70% of the blank, it<br>has cytotoxic potential. | Viab.% of 100% test article<br>extract is 6.1%<br><br>It means the proposed<br>device have potential toxicity<br>to L-929 in the MTT method |
| 4 | ISO 10993-11: 2017<br>Biological evaluation of<br>medical devices — Part<br>11: Tests for systemic<br>toxicity | To evaluate the<br>potential for medical<br>device materials to<br>cause adverse<br>systemic reactions. | Within the monitoring<br>period (72 h), if the<br>toxicosis response of<br>testing group is not<br>greater than that of<br>control group, the<br>testing sample is<br>regarded as acceptable. | There was no evidence of<br>systemic toxicity from the<br>extract. |
| 5 | ISO 10993-7 standards<br>for EO/ECH residual<br>testing | This part of ISO<br>10993 specifies<br>allowable limits for<br>residual ethylene<br>oxide (EO) | Limit<br>(< 24 h) EO 4 mg<br>ECH 9 mg<br>Prolonged<br>(> 24 h < 30 d) EO 60<br>mg/30 d<br>ECH 60 mg/30 d | EO residue: ≤ 4mg in<br>the first 24h; ≤ 60mg in<br>the first 30d; EO<br>residue shall also ≤<br>10ug/g;<br>ECH residue: ≤ 9mg in<br>the first 24h; ≤ 60mg in<br>the first 30d. |
| 6 | ASTM D6124-06<br>(Reapproved 2017),<br>Standard Test Method<br>for Residual Powder on<br>Medical Gloves | This standard is<br>designed to<br>determine the amount<br>of residual powder (or<br>filter-retained mass)<br>found<br>on medical gloves | powder residue limit of<br>2.0 mg | 0.1mg/glove |
| 7 | ASTM<br>D5151-19, Standard Test<br>Method for Detection of<br>Holes in Medical Gloves.<br>12/23/2019 | This test method<br>covers the detection<br>of holes in<br>medical gloves. | Samples number: 200<br>gloves<br>AQL: 1.5 (ISO 2859)<br>Criterion ≤7 gloves for<br>water leakage | 0 glove water leakage found |
| 8 | ASTM D5712-15<br>Standard Test Method<br>for Analysis of Aqueous<br>Extractable Protein in<br>Natural Rubber in Latex,<br>Natural Rubber, and<br>Elastomeric Products<br>Using the Modified<br>Lowry Method | This test method, for<br>the determination of<br>protein levels<br>in latex, is primarily<br>intended to test NR,<br>latex, and elastomeric<br>materials for residual<br>protein content. | Have a recommended<br>aqueous soluble protein<br>content limit of 200<br>ug/dm² | 52ug/dm² |
| 9 | ASTM<br>D3577-19, Standard<br>Specification for Rubber<br>Surgical Gloves | The specification is<br>intended as a<br>reference to the<br>performance and<br>safety of rubber<br>surgical gloves. The<br>safe and proper use<br>of rubber surgical<br>gloves is beyond the<br>scope of this<br>specification. | Dimensions:<br>-6.5: width 83±6mm<br>Length ≥265 mm<br>-7: width 89±6mm<br>Length ≥265 mm<br>-7.5: width 95±6mm<br>Length ≥265 mm<br>-8: width 102±6mm<br>Length ≥265 mm<br>Thickness:<br>-Finger ≥0.10 mm<br>-Palm ≥0.10 mm<br>-Cuff ≥0.10 mm<br><br>Physical properties:<br>● Before aging<br>● Tensile strength<br>≥17MPa<br>● Ultimate<br>● Elongation ≥<br>650%<br>● Stress at 500%<br>Elongation ≤ 7.0<br>MPa<br>● After Accelerated<br>Aging<br>● Tensile strength<br>≥12MPa<br>● Ultimate Elongation<br>≥ 490% | Dimensions:<br>6.5: width: 83-84 mm<br>Length 280-289 mm<br>Thickness:<br>Finger 0.230-0.260 mm<br>Palm 0.188-0.207 mm<br>Cuff 0.137-0.151 mm<br>7: width 91-93 mm<br>Length 271-278 mm<br>Thickness:<br>Finger 0.211-0.241 mm<br>Palm 0.181-0.193 mm<br>Cuff 0.133-0.144 mm<br>7.5: width 96-98 mm<br>Length 273-280 mm<br>Thickness:<br>Finger 0.218-0.237mm<br>Palm 0.180-0.192 mm<br>Cuff 0.136-0.146 mm<br>8: width 103-105 mm<br>Length 268-283 mm<br>Thickness:<br>Finger 0.221-0.272 mm<br>Palm 0.189-0.212 mm<br>Cuff 0.143-0.153 mm<br><br>Physical properties: Before<br>aging<br>-Tensile strength 25.2-30.9<br>MPa<br>-Ultimate Elongation 721% -<br>777%<br>-Stress at 500% Elongation<br>6.5-7.0 MPa<br>After Accelerated Aging<br>-Tensile strength 23.0-29.0<br>MPa<br>-Ultimate Elongation 680% -<br>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.