Single-Use Latex Sterile Surgical Gloves (SG100)

K231446 · Fitone Latex Products Co., Ltd. Guangdong · KGO · Sep 22, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K231446
• Device Name: Single-Use Latex Sterile Surgical Gloves (SG100)
• Applicant: Fitone Latex Products Co., Ltd. Guangdong
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Sep 22, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

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.

Device Story

Single-use sterile surgical gloves made of natural rubber latex; intended for use by operating room personnel to protect surgical wounds from contamination. Device is provided radiation-sterilized (SAL 10^-6) and is powder-free. Available in multiple sizes (6 through 9). Used in clinical/surgical settings to provide a barrier between the wearer and the patient. Benefits include reduction of contamination risk during surgical procedures. Device is disposable.

Clinical Evidence

No clinical data. Bench testing only. Testing included physical dimensions, tensile strength, elongation, hole detection (ASTM D5151), residual powder content (ASTM D6124), protein content (ASTM D5712), and biocompatibility (ISO 10993-5, 10, 11). All results met acceptance criteria.

Technological Characteristics

Natural rubber latex; powder-free; radiation sterilized (SAL 10^-6); shelf life 3 years. Complies with ASTM D3577-19 (Type I), ASTM D5151-19, ASTM D6124-06, and ASTM D5712-15. Biocompatibility per ISO 10993-1, 10, and 11.

Indications for Use

Indicated for operating room personnel to protect surgical wounds from contamination. Intended for use by healthcare professionals.

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 Latex Surgical Gloves Powder Free (K212848)

Submission Summary (Full Text)

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

K231446

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)

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

Preparation date: Sept. 19, 2023

#### Submission Correspondent

Ms. Kyra Kang Landlink Healthcare Technology (Shanghai) Co., Ltd. E-mail: [e-mail]

#### 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 device<br>K231446 | Predicate device<br>K212848 | Discussion |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product name | Single-Use Latex<br>Sterile Surgical<br>Gloves | Sterile Latex Surgical<br>Gloves Powder Free | Similar |
| Indications For<br>Use | The Single-Use Latex<br>Sterile Surgical Glove<br>is a device made of<br>natural rubber<br>intended to be worn<br>by operating room<br>personnel to protect a<br>surgical wound from<br>contamination. | A Sterile Latex Surgical<br>Gloves Powder Free 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. | Similar |
| Product Code | KGO | KGO | Same |
| Regulation<br>Number | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Powdered or<br>Powder free | Powdered free | Powdered free | Same |
| Classification as<br>per ASTM<br>D3577- 2019 | Type I - gloves<br>compounded primarily<br>from natural rubber<br>latex | Type I - gloves<br>compounded primarily from<br>natural 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 and<br>Labeling | Meet FDA's<br>Requirement | 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 the<br>standard | | Remarks |
|-----------------------------------------------------|------------------------------------------------------|------------------------------------------------------|----------------------------------------------------------------------------------------------|
| | Subject device<br>K231446 | Predicate device<br>K212848 | |
| Dimensions Length:-<br>Min 265 mm | 281 mm | 380 mm | Similar<br>Meets ASTM D3577-2019,<br>Standard Specification for<br>Rubber Surgical Gloves |
| Size | | | |
| 6.0 (76+/-6mm) | 76mm | 74mm | Similar |
| 6.5 (83+/-6mm) | 84mm | 86mm | Meets ASTM D3577-2019,<br>Standard Specification for<br>Rubber<br>Surgical 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 Tip<br>Min<br>0.10 mm | Cuff- 0.16mm<br>Palm-0.18mm<br>Finger Tip-<br>0.22mm | Cuff- 0.12mm<br>Palm-0.16mm<br>Finger Tip-<br>0.21mm | |
| Tensile Strength<br>24Mpa minimum<br>Before Aging | 37Mpa | 28.55Mpa | Similar<br>Meets ASTM D3577-2019,<br>Standard Specification for |
| Ultimate Elongation<br>750% minimum<br>Before Aging | 814% | 870% | Rubber Surgical Gloves |
| Stress at 500%<br>5.5 MPa Max<br>Before Aging | 3.5Mpa | 5.1Mpa | |
| Tensile Strength 18Mpa<br>minimum<br>After Aging | 32.49Mpa | 23.48Mpa | Similar<br>Meets ASTM D3577-2019,<br>Standard Specification for<br>Rubber<br>Surgical Gloves |
| Ultimate Elongation<br>560% minimum After<br>Aging | 760% | 731% | |

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| Characteristics | Acceptance criteria of the<br>standard | | Remarks |
|---------------------------------------------------------------------------|----------------------------------------|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject device<br>K231446 | Predicate<br>device<br>K212848 | |
| Freedom from<br>Holes<br>AQL 1.5 | AQL 1.5 | AQL 1.0 | Similar<br>Meets ASTM D3577-2019 and<br>ASTM D5151-2019,<br>Standard Test Method for<br>Detection of Holes in Medical<br>Gloves |
| Powder residue for<br>powder free glove<br>Powder content <<br>2 mg/Glove | 0.21 mg/Glove | 0.40 mg/Glove | Similar<br>Meets ASTM D3577-2019 and<br>ASTM<br>D6124-06,(Reapproved 2017),<br>Standard Test Method for<br>Residual Powder on Medical<br>Gloves |

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| Characteristics | Biocompatibility | Acceptance criteria of the standard | | Remarks |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|---------|
| | | Subject device<br>K231446 | Predicate device<br>K212848 | |
| Skin Irritation &<br>Skin Sensitization | ISO 10993-<br>10,Biological<br>evaluation of medical<br>devices - Part 10:<br>Tests for irritation and<br>skin<br>sensitization | Non- irritant and<br>Non-Sensitizer | Non- irritant and<br>Non-Sensitizer | Same |
| In vitro cytotoxicity | ISO 10993-<br>5:2009(E),Biological<br>Evaluation of Medical<br>Devices - Part 5-Tests<br>for<br>in vitro Cytotoxicity | Cytotoxic | Cytotoxic | Same |
| Material Mediated<br>pyrogenicity | ISO 10993-11:2017(E)<br>,Biological Evaluation<br>of Medical Devices -<br>Part 11, Tests for<br>Systemic Toxicity and<br>USP 41<br><151>Pyrogen Test | Non pyrogenic | No data available | ----- |
| Acute Systemic<br>Toxicity | ISO 10993-11:2017(E)<br>,Biological Evaluation<br>of Medical Devices -<br>Part 11, Tests for<br>Systemic Toxicity | Under the<br>conditions of<br>study the<br>device extracts<br>do not pose an<br>acute systemic<br>toxicity<br>concern | Under the<br>conditions of study<br>the<br>device extracts do<br>not pose an acute<br>systemic toxicity<br>concern | Same |
| Bacterial<br>Endotoxin | USP 42 <85> | <20EU/pair of<br>gloves | <20EU/pair of<br>gloves | 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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| Test<br>Methodology | Purpose | Acceptance Criteria | Results |
|-------------------------|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| ASTM D3577-19 | Physical Dimension | The actual measured<br>dimension of the<br>gloves shall meet<br>the stated<br>tolerance specified<br>in Table 2 of the<br>ASTM D3577-19 | Meets the<br>requirement |
| ASTM D3577-19 | Determination of<br>Physical Properties | Before and after<br>Accelerated aging,<br>the gloves shall<br>conform to the<br>physical<br>requirements in<br>Table 3 of ASTM<br>D3578-19 | Meets the<br>requirement |
| ASTM D5151-19 | Water Leak Test for<br>Detection of Holes | The gloves shall be<br>free from hole<br>when tested in<br>accordance with<br>the method given<br>in ASTM D5151 | Meets the<br>requirement AQL<br>1.5 |
| ASTM D6124-<br>06(2017) | Residual Powder<br>Content Test | The powder residue<br>content shall be<br>not more than<br>2mg per gloves. | Meets the<br>requirement |
| ASTM D5712-15 | Protein Content | <200µg/dm² | Meets the<br>requirement |
| ISO 10993-10:<br>2010 | Skin Sensitization | Non-sensitizing | Meets the<br>requirement |
| ISO 10993-10:<br>2010 | Skin irritation | Non-irritating | Meets the<br>requirement |
| ISO 10993-11:<br>2017 | Systemic toxicity | Non-systemic toxicity | Meets the<br>requirement |

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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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