JR.MEDIK Latex Surgeon’s Gloves Powder Free

K192328 · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · KGO · Mar 10, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K192328
• Device Name: JR.MEDIK Latex Surgeon’s Gloves Powder Free
• Applicant: Jr Engineering & Medical Technologies (M) Sdn. Bhd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Mar 10, 2020
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Story

Sterile, disposable natural rubber latex surgeon's gloves; intended for use by operating room personnel to protect surgical wounds from contamination. Device acts as physical barrier between clinician and patient. Manufactured per ASTM D3577-09(2015) standards. Sterilized via Gamma irradiation to achieve SAL 10^-6. Available in multiple sizes with uniform creamy white color. Provides protection against contamination during surgical procedures.

Clinical Evidence

Bench testing only. Device verified against ASTM D3577-09, ASTM D5151-06, ASTM D6124-06, ASTM D5712-15, ASTM D6499-18, and ASTM F1929-2015. Biocompatibility testing performed per ISO 10993-10 and ISO 10993-11. Sterilization validated per ISO 11137-1 and ISO 11137-2. Pyrogen testing performed per USP 41 <151>. Results confirm compliance with all design specifications and safety standards.

Technological Characteristics

Material: Natural rubber latex (ASTM D3577-09). Form factor: Sterile, powder-free surgeon's gloves. Sterilization: Gamma irradiation (SAL 10^-6). Physical properties: Tensile strength >24 MPa (before aging), ultimate elongation >750% (before aging), pinhole AQL 1.0. Protein content: <50 µg/dm². Biocompatibility: Non-irritant, non-sensitizer, non-pyrogenic.

Indications for Use

Indicated for use by operating room personnel to protect surgical wounds from contamination. No specific age or gender restrictions.

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

• Pristeen Latex Surgeon's Gloves powder free (K172942)

Reference Devices

• Medismart+ Latex Surgeon's Gloves powder (K151114)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

March 10, 2020

JR Engineering & Medical Technologies (M) SDN.BHD. % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr, STE 114 Aurora, Illinois 60504

Re: K192328

Trade/Device Name: JR MEDIK Latex Surgeon's Gloves Sterile Powder Free Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO Dated: February 12, 2020 Received: February 14, 2020

Dear Manoj Zacharias:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 Claverie, M.S. 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) K192328

Device Name

JR Medic Latex Surgeon's Gloves Sterile Powder Free

Indications for Use (Describe)

A latex surgeon's glove is a 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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# 510K SUMMARY

# K192328

# as required by: 21 CFR § 807.92

## A. APPLICANT INFORMATION

| Submitter Name | JR Engineering & Medical Technologies (M)<br>SDN.BHD. |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Submitted | 24th Nov 2019 |
| Address | Lot 8 &10, Jalan Zurah 3 & Lot 1 & 3, Jalan Zurah 3A/1<br>Pusat Perindustrian 2, 44200 Rasa,<br>Hulu Selangor, Selangor Darul Ehsan, Malaysia. |
| Phone | [phone] |
| Fax | [phone] |
| E-mail | [e-mail] |
| Contact Person | Mr. Ganesan Subramaniam |
| Designation | Managing Director |
| Contact Number | [phone] |
| Contact Email | [e-mail] |

# B. US AGENT & CONTACT PERSON INFORMATION

| US agent & contact person name | Manoj Zacharias |
|--------------------------------|--------------------------------------------------------------------------|
| Address | Liberty Management Group Ltd.<br>2871, Coastal Dr. Aurora, IL-60503, USA |
| Phone | [phone] |
| Fax | [phone] |
| E-mail | [e-mail] |

## C. DEVICE IDENTIFICATION

| Common Name | Surgeon's Gloves |
|--------------------------------------|-----------------------------------------------------|
| Device Name | Surgeon's Gloves powder free |
| Product proprietary<br>or trade name | JR MEDIC LATEX SURGEON'S GLOVES STERILE POWDER FREE |
| Classification name | Surgeon's Gloves |
| Device Classification | I |
| Product Code | KGO |
| Regulation Number | 21 CFR 878.4460 |
| Review Panel | General Hospital |

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### D.PREDICATE DEVICE INFORMATION

| Device | Name of device | 510k Number | 510K Owner |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|-------------------------------------------------------------------------------------------------------------------------|
| Predicate<br>device | Pristeen Latex Surgeon's Gloves<br>powder free with protein content<br>labeling claim of 50 $\mu g/dm^2$ or less<br>per glove of extractable protein | K172942 | Beta Healthcare Products<br>Pvt.Ltd, Plot No 21B,<br>Cochin Special Econmic<br>Zone, Kakkanad, Kerala,<br>India-682037. |
| Reference<br>device | Medismart+ Latex Surgeon's<br>Gloves powder with protein content<br>labeling claim of 50<br>$\mu g/dm^2$ or less per glove of<br>extractable protein | K151114 | St.Marys Rubbers Pvt.Ltd,<br>Koovappally P.O,<br>Kanjirappally, Kottayam<br>District, Kerala State,<br>India-686518 |

### E. DESCRIPTION OF THE DEVICE

The proposed device, JR Medic Latex Surgeon's Gloves Sterile Powder Free with protein content labeling claim of 50 µg/ dm² or less per glove of extractable protein is a sterile 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, as per standard ASTM D35 77 -09(2015), Standard Specification for Rubber Surgical Gloves.

The classification is: Type I - gloves compounded primarily from natural rubber latex.

The proposed device is Powder Free Latex Surgeon's Gloves, and variants of different sizes. All variants share the same color, creamy, white.

The proposed device is sterilized using Gamma irradiation method to achieve the Sterility Assurance Level (SAL) of 10 and place in a sterility maintained package to ensure a shelf life of 3 years.

### F. INDICATION FOR USE

A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

### G. TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE

a. General Characteristics Comparison

| Characteristic | Subject device<br>K192328 | Predicate device<br>K172942 | comparison |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product Code | KGO | KGO | Same |
| Regulation No. | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Class | I | I | Same |
| Intended Use | A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination | A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination | Similar |

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| Powdered or<br>Powder free | powered free | powered free | Same |
|-------------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------|-----------|
| Compounding<br>Classification | Type I - gloves compounded<br>primarily from natural rubber<br>latex | Type I - gloves compounded<br>primarily from natural rubber latex | Same |
| Sterilization | Radiation,<br>SAL- 10-6 | ETO/as well as<br>Radiation, SAL- 10-6 | Different |
| Labeling | Meet FDA's label<br>Requirements | Meet FDA's label<br>Requirements | Same |
| Special label<br>claim | Protein content labeling claim of<br>50<br>µg/dm² or less | Protein content labeling claim of<br>50<br>µg/dm² or less | Same |
| Type of use | Over the counter use | Over the counter use | Same |

### b. Technological Characteristics Comparison

| Specification and physical properties per ASTM<br>D3577- 09(Reapproved 2015), Standard Specification<br>for Rubber Surgical Gloves. | Subject<br>device<br>K192328 | Predicate<br>device<br>K172942 | Remarks | |
|-------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|--------------------------------|---------|---------|
| Dimensions Length: Min 265 mm | 300 mm | 282 mm | Similar | |
| Width | | | | |
| Size | 6.0(76+/-6mm) | 78mm | 78mm | Similar |
| | 6.5(83+/-6mm) | 85mm | 84mm | |
| | 7.0(89+/-6mm) | 88mm | 91mm | |
| | 7.5(95+/-6mm) | 97mm | 97mm | |
| | 8.0(102+/-6mm) | 103mm | 103mm | |
| | 8.5(108+/-6mm) | 110mm | 109mm | |
| | 9(114+/-6mm) | 116mm | 115mm | |
| Thickness for all sizes | | | | |
| Cuff, Palm, Finger Tip Min 0.10 mm | Cuff- 0.11mm | Cuff- 0.13mm | Similar | |
| | Palm- 0.18mm | Palm-0.16mm | | |
| | Finger Tip-<br>0.21mm | Finger Tip-<br>0.18mm | | |
| Physical Properties Before Ageing -for all sizes | | | | |
| Tensile Strength 24Mpa minimum | 26.0Mpa | 28.0Mpa | Similar | |
| | Ultimate Elongation 750% minimum | 860% | 920% | |
| | Stress at 500% 5.5 MPa Max | 2.7 Mpa | 3 Mpa | |
| Physical Properties After Ageing -for all sizes | | | | |
| Tensile Strength 18Mpa minimum | 22.0Mpa | 24.0Mpa | Similar | |
| | Ultimate Elongation 560% minimum | 725% | 750% | |
| | Freedom from Holes AQL 1.5, AST M D5151-06,<br>(2015), Standard Test Method for Detection of Holes | AQL 1.0 | AQL 1.0 | Similar |

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| in Medical Gloves | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|-----------------------------------------|-----------|
| Powder content < 2 mg/Glove,<br>ASTM D6124-06, (2017), Standard Test Method for<br>Residual Powder on Medical Gloves | 0.34<br>mg/Glove | 0.3<br>mg/glove | Similar |
| Protein Content < 50 $\mu$ g/ dm²,<br>ASTM D5712-15, Standard Test Method for the<br>Analysis of Aqueous Extractable Protein in Natural<br>Rubber and Its Products Using the Modified Lowry<br>Method;<br>ASTM D6499-18, Standard Test Method for the<br>Immunological Measurement of Antigenic Protein in<br>Natural Rubber and Its Products | 43 $\mu$ g/ dm² | 40 $\mu$ g/ dm² | Similar |
| Biocompatibility | | | |
| ISO 10993-10, Biological evaluation of medical<br>devices - Part 10: Tests for irritation and skin<br>sensitization | Non- irritant<br>and Non-<br>Sensitizer | Non- irritant<br>and Non-<br>Sensitizer | Same |
| ISO 10993-5: 2009 (E), Biological Evaluation of<br>Medical Devices - Part 5-Tests for in vitro Cytotoxicity | Cytotoxic | Non cytotoxic | Different |
| ISO 10993-11: 2017(E). Biological Evaluation of<br>Medical Devices - Part 11, Tests for Systemic Toxicity, | No systemic<br>toxicity under<br>the conditions<br>of the test | Not tested | Different |
| USP 41 <151> Pyrogen Test | Non pyrogenic | Non pyrogenic | same |

# H. SUMMARY OF NON-CLINICAL PERFORMANCE DATA

| Sl.No | Criteria | Specification as per<br>ASTMD3577-09,<br>Standard<br>Specification for<br>Rubber Surgical<br>Gloves | Average value of<br>subject device | Compliance with the<br>ASTMD 3577-09,<br>Standard Specification<br>for Rubber Surgical<br>Gloves |
|-------|-----------|-----------------------------------------------------------------------------------------------------|------------------------------------|--------------------------------------------------------------------------------------------------|
| 1 | Length | | | |
| | Size 6 | Min 265mm | 306mm | Yes |
| | Size 6'/2 | Min 265mm | 306mm | Yes |
| | Size 7 | Min 265mm | 305mm | Yes |
| | Size 7'/2 | Min 265mm | 305mm | Yes |
| | Size 8 | Min 265mm | 305mm | Yes |
| | Size 8'/2 | Min 265mm | 305mm | Yes |
| | Size 9 | Min 265mm | 305mm | Yes |

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| 2 | Width | | | |
|---|---------------------------------|------------|--------|-----|
| | Size 6 | 76+/-6mm | 78mm | Yes |
| | Size 6'⁄2 | 83+/-6mm | 85mm | Yes |
| | Size 7 | 89+/-6mm | 88mm | Yes |
| | Size 7'⁄2 | 95+/-6mm | 97mm | Yes |
| | Size 8 | 102+/-6mm | 103mm | Yes |
| | Size 8'⁄2 | 108+/-6mm | 110mm | Yes |
| | Size 9 | 114+/-6mm | 116mm | Yes |
| 3 | Finger Thickness<br>(All sizes) | Min 0.10mm | 0.21mm | Yes |
| 4 | Palm Thickness<br>(All sizes) | Min 0.10mm | 0.18mm | Yes |
| 5 | Cuff Thickness<br>(All sizes) | Min 0.10mm | 0.11mm | Yes |

| SL.NO | Criteria | Specification as per<br>ASTMD3577-09<br>Standard<br>Specification for<br>Rubber Surgical<br>Gloves | Average value of<br>subject device | Whether subject device<br>complied with the<br>ASTMD3577 -09,<br>Standard Specification<br>for Rubber Surgical<br>Gloves |
|-------|-------------------------------------------------------|----------------------------------------------------------------------------------------------------|------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| 6 | Tensile Strength | | | |
| | Before aging<br>(All sizes) | 24Mpa minimum | 26.0Mpa | Yes |
| | After aging@<br>70°±2C for<br>166±2 hr<br>(All sizes) | 18Mpa minimum | 22.0Mpa | Yes |
| 7 | Ultimate Elongation | | | |
| | Before aging<br>(All sizes) | 750% minimum | 860% | Yes |

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| | After aging@<br>70°±2C for<br>166±2 hr<br>(All sizes) | 560% minimum | 725% | Yes |
|---|-------------------------------------------------------|--------------|---------|-----|
| 8 | Stress at 500%<br>before ageing<br>(All sizes) | 5.5 MPa Max | 2.7 Mpa | Yes |
| 9 | Pinhole AQL | | | |
| | Before aging<br>(All sizes) | Max 1.5 | 1.0 | Yes |
| | After aging@<br>70°C for 7 days<br>(All sizes) | Max 1.5 | 1.0 | Yes |

Bench tests were conducted to verify that the proposed device met all design specifications or acceptance criteria found in the test method or standard. The test results demonstrated that the proposed device met design specifications or acceptance criteria with the following standards:

ASTM D3577-09(15):- Standard Specification for Rubber Surgical Gloves.

ASTM D 5151-06 (2015):-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 D6499-18:-Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and Its Products.

ASTM F 1929-2015:- Standard Test Method for Detecting Seal Leaks in Porous Meckaging by Dye Penetration.

ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

ISO 10993-11:2017(E) Biological Evaluation of Medical Devices - Part 11, Tests for Systemic Toxicity and Biological Tests

USP 41 <151> Pyrogen Test

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

### I. CONCLUSION

The conclusion drawn from the nonclinical tests demonstrates that. JR MEDIC Latex Surgeon's Gloves Sterile Powder Free is as safe, as effective, and performs as well as or better than the legally marketed predicated device K172942.