Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein

K190632 · Lenora Glove Pvt , Ltd. · KGO · Oct 24, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K190632
• Device Name: Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein
• Applicant: Lenora Glove Pvt , Ltd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Oct 24, 2019
• 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 glove; powder-free via polymer coating. Used by operating room personnel to protect surgical wounds from contamination. Device provides a physical barrier; performance verified against ASTM D3577-09 standards for dimensions, physical properties, and freedom from holes. Sterilized via Ethylene Oxide or Gamma irradiation to SAL 10^-6. Available in multiple sizes (5.5 to 9).

Clinical Evidence

Bench testing only. No clinical data. Testing included physical property verification (tensile strength, elongation, stress), freedom from holes (ASTM D5151), residual powder content (ASTM D6124), extractable protein analysis (ASTM D5712, D6499), and biocompatibility (ISO 10993-10). All results met ASTM D3577-09 acceptance criteria.

Technological Characteristics

Material: Natural rubber latex (ASTM D3577-09). Form: Powder-free (polymer coated). Sterilization: Ethylene Oxide or Gamma irradiation (SAL 10^-6). Biocompatibility: ISO 10993-10 compliant. Dimensions/Physicals: Compliant with ASTM D3577-09. Protein content: ≤ 50 µg/dm².

Indications for Use

Indicated for operating room personnel to protect a surgical wound 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 Glove powder free with protein content labeling claim of 50 µg/dm² or less per glove of extractable protein (K172942)

Reference Devices

• Medismart+ Latex Surgeon's Glove powder free with protein content labeling claim of 50 µg/dm² or less per glove of extractable protein (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 and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

October 24, 2019

Lenora Glove PVT LTD. % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Drive Ste 114 Aurora, Illinois 60504

Re: K190632

Trade/Device Name: Latex Surgeon's Gloves Powder Free with protein content labeling claim of 50ug/dm2 or less per glove of extractable protein Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I Product Code: KGO Dated: September 18, 2019 Received: September 24, 2019

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.

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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 (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 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.

For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 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) K190632

#### Device Name

Latex Surgeon's Gloves Powder Free with protein content labeling claim of 50 µg/dm² or less per glove of extractable protein

#### 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)

| | <div> <svg height="16" width="16"> <polygon points="1,0 15,0 15,14 1,14" style="fill:none;stroke:black;stroke-width:1"></polygon> </svg> </div> |
|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <div> <svg height="16" width="16"> <polygon points="1,0 15,0 15,14 1,14" style="fill:none;stroke:black;stroke-width:1"></polygon> <polygon points="3,3 13,3 13,12 3,12" style="fill:none;stroke:black;stroke-width:3"></polygon> </svg> </div> |

| | Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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# LENORA GLOVE PVT.LTD. SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR LATEX SURGEON'S GLOVE POWDER FREE

## 510K SUMMARY as required by: 21CFR § 807.92

K190632

# A. APPLICANT INFORMATION

| 1. | Submitter Name | LENORA GLOVE PVT. LTD. |
|----|----------------|--------------------------------------------------------------------------------------------------------------|
| | Date Submitted | September 18, 2019 |
| | Address | Plot No:15/104-1, Rottigoundanur,<br>Thirumalayampalayam P.O., Coimbatore,<br>Tamilnadu State, India-641 105 |
| | Phone | [phone], 2656 941 |
| | Fax | 1 [phone] |
| | E-mail | [e-mail] |
| | Contact Person | ANTONY KURIYAN |
| | 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>75 Executive Dr. STE 114, Aurora, IL-<br>60504, USA. |
| Phone | [phone] |
| Fax | [phone] |
| E-mail | [e-mail] |

# C. DEVICE IDENTIFICATION

| Common Name | Surgeon's Glove |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Latex Surgeon's Glove powder free with<br>protein content labeling claim of 50 µg/dm²<br>or less per glove of extractable protein |
| Product proprietary or trade<br>name | Latex Surgeon's Glove powder free with<br>protein content labeling claim of 50 µg/dm²<br>or less per glove of extractable protein |
| Classification name | Surgeon's Glove |
| Device Classification | 1 |
| Product Code | KGO |
| Regulation Number | 21 CFR 878.4460 |
| Review Panel | Gen & Plastic Surgery |
| | |

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#### SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR LATEX SURGEON'S GLOVE POWDER FREE

### D.PREDICATE DEVICE INFORMATION

| | Name of devices | 510k Number | 510K Owner |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|------------------------------------------------------------------------------------------------------------------------|
| Predicate device | “PRISTEEN” Latex Surgeon's<br>Glove powder free with<br>protein content labeling claim<br>of 50 $µg/dm^2$ or less per<br>glove of extractable protein | K172942 | Beta Health Care products<br>Pvt.Ltd,Plot No 21B,<br>Cochin Special Economic<br>Zone,Kakkanad, kerala,<br>India-682037 |
| Reference device | “Medismart+” Latex Surgeon's<br>Glove powder free with<br>protein content labeling claim<br>of 50 $µg/dm^2$ or less per<br>glove of 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, Latex Surgeon's Gloves 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 fromcontamination.

The proposed device is made of' natural rubber latex, as per standard ASTM D35 77-09(2015).

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 either using Ethylene Oxide Sterilization or Gamma irradiation method to achieve the Sterility Assurance Level (SAL) of 10 6and place in a sterility maintenance 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.

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## SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR LATEX SURGEON'S GLOVE POWDER FREE

# G. TECHNOLOGICAL COMPARISON

#### a. General Characteristics Comparison

| Characteristic | Subject device<br>K190632 | Predicate device<br>K172942 | Reference device<br>K151114 | Comparison |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product Code | KGO | KGO | KGO | Same |
| Regulation No. | 21 CFR 878.4460 | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Class | 1 | 1 | 1 | Same |
| Intended Use for<br>Latex Surgeon's<br>Gloves Powder<br>Free, with protein<br>content labeling<br>claim of<br>50µg/dm² or less<br>per glove of<br>extractable<br>protein. | 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. | A latex surgeon<br>Surgeons glove is<br>a device made of<br>natural rubber<br>intended to be<br>worn by<br>operating room<br>personnel to<br>protect a surgical<br>wound from<br>contamination | A latex surgeon<br>Surgeons glove is<br>a device made of<br>natural rubber<br>intended to be<br>worn by<br>operating room<br>personnel to<br>protect a surgical<br>wound from<br>contamination | Similar |
| Powdered or<br>Powder free | Powder free | Powder free | Powder free | Same |
| Method of<br>powder free | Polymer coat | same | same | Same |
| Classification per<br>ASTMD3577-99 | Type I - gloves compounded<br>primarily from natural<br>rubber latex | Type I - gloves<br>compounded<br>primarily from<br>natural rubber<br>latex | Type I - gloves<br>compounded<br>primarily from<br>natural rubber<br>latex | Same |
| Sterilization | ETO/as well as Radiation,<br>SAL- 10-6 | ETO/as well as<br>Radiation,<br>SAL- 10-6 | ETO/as well as<br>Radiation,<br>SAL- 10-6 | Same |
| Label and<br>Labeling | Meet FDA's Requirements | Meet FDA's<br>Requirements | Meet FDA's<br>Requirements | Same |
| Special label<br>claim | Protein content labeling<br>claim of 50 µg/dm² or less<br>per glove of extractable<br>protein for Latex Surgeon's<br>Gloves Powder Free. | Same | Same | Same |
| Type of use | Over the counter use | Over the counter<br>use | Over the counter<br>use | Same |

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#### SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR LATEX SURGEON'S GLOVE POWDER FREE

| Characteristics | Acceptance criteria of the standard | | | |
|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|------------|
| | Subject device<br>K190632 | Predicate device<br>K172942 | Reference device<br>K151114 | Comparison |
| Dimensions | ASTM D3577-<br>09((Reapproved 2015)) | ASTM D3577 | ASTM D3577 | Similar |
| Physical<br>Properties | ASTM D3577-09<br>(Reapproved 2015) | ASTM D3577 | ASTM D3577 | Similar |
| Freedom from<br>Holes | ASTM D3577 and<br>AST MD5151-06,<br>(Reapproved 2015) | ASTM D3577 and<br>AST M D5151 | ASTM D3577 and<br>AST M D5151 | Similar |
| Powder residue<br>for powder free<br>glove | ASTM D3577 and ASTM<br>D6124-06, (Reapproved<br>2017)<br>Powder content<br>< 2 mg/Glove | ASTM D3577 and<br>ASTM D6124,<br>Powder content<br>< 2 mg/Glove | ASTM D3577 and<br>ASTM D6124,<br>Powder content<br>< 2 mg/Glove | Similar |
| Protein Content | ASTM D3577, ASTM<br>D5712-15 and ASTM<br>D6499-16 | ASTM D3577,<br>ASTM D5712 and<br>ASTM D6499 | ASTM D3577,<br>ASTM D5712 and<br>ASTM D6499 | Similar |
| Biocompatibility<br>(Irritation,<br>Sensitization,<br>Acute Systemic<br>Toxicity) | ISO 10993-10<br>Non- irritant,<br>Non-Sensitizer and Non-<br>Toxic | ISO 10993-10 | ISO 10993-10 | Similar |

#### Technological Characteristics Comparison b.

## H. Summary of Non-Clinical Testing

Bench tests were conducted to verify that the proposed device met all design specifications as the predicate devices. The standards used in this submission and the test results demonstrated that the proposed device complies with the following standards:

- . ASTM D3577-09 (2015):- 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.

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SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR LATEX SURGEON'S GLOVE POWDER FREE

- 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 Medical Packaging by Dye Penetration.
- . ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
- 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
- 1S01137-2:2013: Sterilization of healthcare products-Radiation-Part2: Establishing the sterilization dose.
- ISO 10993-7:2008:-Biological evaluation of medical devices --: Ethylene oxide ● sterilization residuals.
- . ISO 11135-1:2014 :- Sterilization of healthcare products -- Ethylene oxide -Part 1: Requirements for development, validation and routine control of a sterilization process for medicaldevices.

A summary of the non-clinical testing results for the subject device is provided below. The standards used in this submission and the test results demonstrate that the proposed device meets the acceptance criteria for the referenced standards.

| | CRITERIA | SPECIFICATION AS | AVERAGE VALUE | WHETHER |
|---|----------------------|------------------|---------------|-----------------|
| | | PER ASTMD3577-09 | OF SUBJECT | SUBJECT DEVICE |
| | | STANDARD | DEVICE | COMPLIED WITH |
| | | | | THE ASTMD3577 - |
| | | | | 09 STANDARD |
| 1 | Length ASTM D3577-09 | | | |
| | Size 5'/2 | Min 265mm | 282 mm | Yes |
| | Size 6 | Min 265mm | 282mm | Yes |
| | Size 6'/2 | Min 265mm | 282mm | Yes |
| | Size 7 | Min 265mm | 282mm | Yes |

SIZES AVAILABLE: - 5'/2, 6, 6'/2, 7, 7'/2, 8, 8'/2, 9

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| LENORA GLOVE PVT.LTD. | | | | |
|--------------------------------------------------------------------------------------|------------------------------------|------------|--------|-----|
| SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR LATEX SURGEON'S<br>GLOVE POWDER FREE | | | | |
| | Size 7'/2 | Min 265mm | 282mm | Yes |
| | Size 8 | Min 265mm | 282mm | Yes |
| | Size 8'/2 | Min 265mm | 282mm | Yes |
| | Size 9 | Min 265mm | 282mm | Yes |
| 2 | Width ASTM D3577-09 | | | |
| | Size 5'/2 | 70+/-6mm | 71mm | Yes |
| | Size 6 | 76+/-6mm | 78mm | Yes |
| | Size 6'/2 | 83+/-6mm | 82mm | Yes |
| | Size 7 | 89+/-6mm | 90mm | Yes |
| | Size 7'/2 | 95+/-6mm | 95mm | Yes |
| | Size 8 | 102+/-6mm | 100mm | Yes |
| | Size 8'/2 | 108+/-6mm | 106mm | Yes |
| | Size 9 | 114+/-6mm | 112mm | Yes |
| 3 | Finger<br>Thickness<br>(All sizes) | Min 0.10mm | 0.20mm | Yes |
| 4 | Palm Thickness<br>(All sizes) | Min 0.10mm | 0.16mm | Yes |
| 5 | Cuff Thickness<br>(All sizes) | Min 0.10mm | 0.13mm | Yes |

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## SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR LATEX SURGEON'S GLOVE POWDER FREE

| | CRITERIA | SPECIFICATION AS<br>PER ASTMD3577-09<br>STANDARD | AVERAGE<br>VALUE OF<br>SUBJECT<br>DEVICE | WHETHER SUBJECT<br>DEVICE COMPLIED<br>WITH THE<br>ASTMD3577 -09<br>STANDARD |
|---|-------------------------------------------------------|--------------------------------------------------|------------------------------------------|-----------------------------------------------------------------------------|
| 6 | Tensile Strength ASTM D3577-09 | | | |
| | Before aging<br>(All sizes) | 24Mpa minimum | 26.5Mpa | Yes |
| | After aging@<br>70°±2C for<br>166±2 hr<br>(All sizes) | 18Mpa minimum | 21.0Mpa | Yes |
| 7 | Ultimate Elongation ASTM D3577-09 | | | |
| | Before aging<br>(All sizes) | 750% minimum | 860% | Yes |
| | 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 | 2.6 Mpa | Yes |
| 9 | Pinhole AQL ASTM D 5151-06(2015) | | | |
| | 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 |

# I. 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 predicated device.