Disposable Sterilized Latex Surgical Gloves

K211953 · Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. · KGO · May 25, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K211953
• Device Name: Disposable Sterilized Latex Surgical Gloves
• Applicant: Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: May 25, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

The Disposable Sterilized Latex Surgical Glove is a device made of nature rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Story

Disposable sterilized surgical glove; manufactured from natural rubber latex; intended for use by operating room personnel. Device acts as a physical barrier to protect surgical wounds from contamination during procedures. Provided EO sterilized with a 3-year shelf life. Available in multiple sizes (6 through 8.5). Performance verified through bench testing against ASTM standards for physical properties, watertightness, and biocompatibility.

Clinical Evidence

No clinical data. Bench testing only, including physical dimensions, tensile strength, ultimate elongation, watertightness (ASTM D5151), residual powder (ASTM D6124), protein content (ASTM D5712), biocompatibility (ISO 10993-10/11), pyrogenicity (USP <151>), and bacterial endotoxin (USP <85>).

Technological Characteristics

Natural rubber latex; powder-free; EO sterilized (SAL 10^6). Complies with ASTM D3577-09(15) (Type 1 gloves). Biocompatibility per ISO 10993-1, 10, 11. Residuals per ISO 10993-7. Dimensions: 265mm length; 0.10mm min thickness. No software or electronic components.

Indications for Use

Indicated for use by operating room personnel to protect a surgical wound from contamination. No specific patient population or contraindications described.

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 (K171550)

Submission Summary (Full Text)

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May 25, 2022

Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd % Alice Huang RA Manager Shanghai Mind-Link Business Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District Shanghai. 200040 China

Re: K211953

Trade/Device Name: Disposable Sterilized Latex Surgical Gloves Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO Dated: April 15, 2022 Received: April 25, 2022

Dear Alice Huang:

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 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,

Bifeng Qian, M.D., Ph.D. Acting 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K211953

Device Name Disposable Sterilized Latex Surgical Gloves

Indications for Use (Describe)

The Disposable Sterilized Latex Surgical Glove is a device made of nature 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

## K211953

#### I. SUBMITTER:

Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. No. 316 National road, Xinju, Changshan Town, Jinxian County, Nanchang City, 331724, Jiangxi Province, China. Contact Person: Jenny Huang

TITLE: International Trade Supervisor

TEL. : [phone]

Email: [e-mail]

Submission Correspondent: Alice Huang Email: alice.huang(@mind-link.net Tel:[phone] Shanghai Mind-link Business Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District, Shanghai

Summary prepared: 05/23/2022

II. DEVICE 510(k) Number: K211953 Name of Device: Disposable Sterilized Latex Surgical Gloves Regulation Number: 21 CFR878.4460 Common Name: Surgeon's Gloves Classification Name: Non-powdered surgeon's glove Regulatory Class: I Product Code: KGO

III. PREDICATE DEVICE

510(k) Number: K171550 Product Name: Sterile Latex Surgical Gloves, Powder Free Manufacture: Sanrea Healthcare Pvt Ltd

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## IV. DEVICE DESCRIPTION

The proposed device, Disposable Sterilized Latex 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-gloves compounded primarily from nature rubber latex." The gloves are powder-free and available in white in sizes 6, 6.5, 7, 7.5, 8, and 8.5.

The proposed device is provided EO sterilized to achieve the sterility Assurance Level (SAL) of 106. The disposable sterilized latex surgical glove shelf life is 3 years.

# V. INDICATIONS FOR USE

The Disposable Sterilized Latex Surgical Glove is a device made of nature rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

# VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Disposable Sterilized Latex Surgical Gloves are compared with the predicate device (Sterile Latex Surgical Gloves, Powder Free, K171550). The results are shown below in the Technological Characteristics Comparison Table:

| DEVICE | Subject Device | Primary Predicate Device<br>(K171550) | Comparison |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Indications For Use | The Disposable Sterilized Latex Surgical Glove is a device made of nature rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. | The Sterile Latex Surgical Gloves, Powder free, is a disposable device made of natural rubber, intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination. | Same |
| Intended Use | The Disposable Sterilized Latex Surgical Glove is a device made of nature rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. | Intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination. | Same |
| Classification<br>Product Code | KGO | KGO | Same |
| Regulation No. | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Class | I | I | Same |
| Powdered or<br>Powdered free | Powdered free | Powdered free | Same |
| Material | Natural Rubber Latex | Natural Rubber Latex | Same |
| Dimensions | Length:<br>Size 6: 265mm, min<br>Size 6.5: 265mm, min<br>Size 7: 265mm, min<br>Size 7.5: 265mm, min<br>Size 8: 265mm, min<br>Size 8.5: 265mm, min<br>Width:<br>Size 6: 76 ±6 mm<br>Size 6.5: 83 ± 6 mm<br>Size 7: 89 ± 6 mm<br>Size 7.5: 95 ± 6 mm<br>Size 8: 102 ± 6 mm<br>Size 8.5: 108 ± 6 mm<br>Palm Thickness: 0.10mm, min<br>Finger Thickness: 0.10mm, min<br>Cuff Thickness: 0.10mm, min | size 7.5 :<br>Length : 300mm<br>size 7.5 :<br>Width : 95mm<br>Palm Thickness: 0.19mm<br>Finger Thickness: 0.22mm<br>Cuff Thickness: 0.14mm | Similar<br>Meeting<br>requirement<br>of ASTM<br>D 3577 |
| Biocompatibility | Under the conditions of the study, not a sensitizer.<br>Under the conditions of the study, not an irritant.<br>Under the conditions of the study, no evidence of acute systemic toxicity. | Non-sensitizing<br>Non-irritating | Similar |
| Tensile strength | Before Aging 24MPa, min<br>After Aging 18MPa, min | Before Aging 31.22MPa<br>After Aging 24.43MPa | Similar<br>Meeting |
| Ultimate<br>Elongation | Before Aging 750%, min<br>After Aging 560%,min | Before Aging 843.09%<br>After Aging 762.28% | requirement<br>of ASTM<br>D 3577 |
| Freedom from | Meets ASTM D5151-06(2015) | Meets ASTM D 5151 -06 | Same |
| Holes | AQL 1.5 | (2011) | |
| Protein Content | Meets ASTM D5712-2015 | Meets ASTM D5712 | Same |
| Powdered residue | Meets ASTM D6124-06(Reapproved 2017) | Meets ASTM D 6124-06(2011) | Same |
| Sterility | EO | EO | Same |
| EtO and ECH residuals | Meets ISO 10993-7:2008 | Meets ISO 10993-7:2008 | Same |
| Shelf life | 3 Years | 3 Years | Same |
| Single Use | YES | YES | Same |
| Label and labeling | Meet FDA's Requirement | Meet FDA's Requirement | Same |

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## VII. SUMMARY OF NON-CLINICAL TESTING

The gloves have the same technological characteristics compared to ASTM or equivalent standards as given below:

- ASTM D5151-06(Reapproved 2015) 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 D3577-09 (Reapproved 2015) Standard Specification for Rubber Surgical 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
- 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
- USP 43-NF 38<151> Pyrogen Test
- USP 43<85> Bacterial Endotoxin Test
- ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials

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- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- . ASTM D7160 Standard Practice for Determination of Expiration Dating for medical Gloves

| Test<br>Method | Standard | Test Purpose | Criteria | Result |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Dimension | ASTM D3577-09(Reapproved<br>2015) Standard Specification for<br>Rubber Surgical Gloves | To determine the length<br>of the gloves | 265mm, min | Pass |
| | ASTM D3577-09(Reapproved<br>2015)Standard Specification for<br>Rubber Surgical Gloves | To determine the width<br>of the gloves | Size 6: 76 ±6 mm<br>Size 6.5: 83 ± 6 mm<br>Size 7: 89 ± 6 mm<br>Size 7.5: 95 ± 6 mm<br>Size 8: 102 ± 6 mm<br>Size 8.5: 108 ± 6 mm | Pass |
| | ASTM D3577-09(Reapproved<br>2015) Standard Specification for<br>Rubber Surgical Gloves | To determine the<br>thickness of the gloves | Palm: 0.10mm, min<br>Finger: 0.10mm, min<br>Cuff: 0.10mm, min | Pass |
| Physical<br>Properties | ASTM D3577-09(Reapproved<br>2015) Standard Specification for<br>Rubber Surgical Gloves | To Determine the<br>physical properties<br>Tensile strength | Before Ageing<br>Tensile Strength<br>24Mpa Minimal for all<br>sizes<br>After Ageing<br>Tensile Strength<br>18Mpa Minimal for all<br>sizes | Pass |
| | ASTM D3577-09(Reapproved<br>2015) Standard Specification for<br>Rubber Surgical Gloves | To Determine the<br>physical properties<br>Ultimate Elongation | Before Ageing<br>Ultimate Elongation<br>750% Min for all sizes<br>After Ageing<br>Ultimate Elongation<br>560% Min for all sizes | Pass |
| Watertight<br>test | ASTM D5151-19 Standard Test<br>Method for Detection of Holes in<br>Medical Gloves | To determine the<br>watertightness of the test<br>gloves | Sample size: 200 pcs<br>Inspection level : GI<br>AQL 1.5<br>Criteria:≤8 pieces | Pass |
| Residual<br>powder | ASTM D6124-06 (Reapproved<br>2017) Standard Test Method for | To determine the<br>residual powder in the | 2 mg per glove or less | Pass |
| | Residual Powder on Medical<br>Gloves | gloves | | |
| Protein<br>content | ASTM D5712 - 15, Standard Test<br>Method for Analysis of Aqueous<br>Extractable Protein in Natural<br>Rubber. | To determine the<br>extractable protein in the<br>gloves. | $200 \mu g/dm^2$ Max for<br>all sizes | Pass |
| Skin<br>Sensitization | ISO 10993-10<br>Biological Evaluation of<br>Medical Devices Test for<br>Irritation and Skin<br>Sensitization. Test done<br>for irritation | The test was designed to<br>evaluate the potential of<br>a test article to cause<br>skin sensitization. | Under the conditions<br>of the study not a<br>sensitizer | Pass |
| Irritation | ISO 10993-10<br>Biological Evaluation of<br>Medical Devices Test for<br>Irritation and Skin<br>Sensitization. Test done<br>for irritation | To evaluate the potential<br>skin irritation caused by<br>test article contact with<br>the skin surface of<br>rabbits. | Under the condition of<br>study not an irritant | Pass |
| Systemic<br>toxicity | ISO 10993-11:2017 biological<br>evaluation of medical devices - part<br>11, tests for systemic toxicity | The test article was<br>evaluated to determine<br>whether leachables<br>extracted from the test<br>article would cause acute<br>systemic toxicity<br>following injection into<br>mice. | Under the conditions<br>of study the device<br>extracts do not pose a<br>systemic toxicity<br>concern | Pass |
| Pyrogen | USP 43-NF 38<151> Pyrogen Test | The test article was<br>evaluated for the risks of<br>febrile reaction in the<br>rabbit to the<br>administration by<br>injection. | Under the condition of<br>study not a pyrogen | Pass |
| Bacterial<br>Endotoxin | USP 43 <85> Bacterial<br>EndotoxinTest | Bacterial EndotoxinTest | <20 EU/ pair of gloves | Pass |
| EO Residue | ISO 10993-7:2008 | Determine if the<br>Ethylene Oxide residues<br>of test article is within<br>the requirements. | ≤10ug/cm² | Pass |
| ECH<br>Residue | ISO 10993-7:2008 | Determine if the<br>Ethylene Chlorohydrin | ≤5mg/cm² | Pass |
| | | residues of test article is<br>within the requirements. | | |

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#### VIII. SUMMARY OF CLINICAL TESTING No clinical testing is included in this submission.

# IX. CONCLUSION

The conclusions drawn from the non-clinical performance data demonstrate that the subject device, Disposable Sterilized Latex Surgical Glove, is as safe, as effective, and performs as well as or better than the legally marketed predicate device K171550.