Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex Surgeon¿s Gloves Powder Free, Polymer coated with protein

K151114 · St. Marys Rubbers Pvt, Ltd. · KGO · Dec 11, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K151114
• Device Name: Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex Surgeon¿s Gloves Powder Free, Polymer coated with protein
• Applicant: St. Marys Rubbers Pvt, Ltd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Dec 11, 2015
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

A latex surgeon's gloves 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 surgical gloves; available in powdered and powder-free (polymer-coated) versions. Used by operating room personnel to protect surgical wounds from contamination. Gloves feature beaded cuffs and textured fingertips/palms. Sterilized via Ethylene Oxide or Gamma irradiation to achieve a Sterility Assurance Level (SAL) of 10^-6. Device provides a physical barrier between the clinician and the patient to prevent cross-contamination during surgical procedures.

Clinical Evidence

No clinical data. Bench testing only. Compliance verified via ASTM D3577-09 (physical properties), ASTM D5151 (pinholes), ASTM D6124 (residual powder), ASTM D5712-10/D6499-12 (protein content), and ISO 10993-10 (biocompatibility/sensitization/irritation).

Technological Characteristics

Natural rubber latex (Type I). Beaded cuff, textured fingertips/palm. Sterilization: ETO or Gamma irradiation (SAL 10^-6). Complies with ASTM D3577-09, ASTM D5151, ASTM D6124, ASTM D5712-10, ASTM D6499-12, ISO 10993-10, ISO 11135-1, and ISO 11137-2.

Indications for Use

Indicated for operating room personnel to protect surgical wounds from contamination. Device is made of natural rubber latex.

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

• SURGTEX Latex Surgeon's Gloves powdered and SURGTEX Latex Surgeon's Gloves powder free (K130450)
• Latex Surgeon's Gloves (powdered and Powder free) (K130301)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three interconnected profiles facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 11, 2015

ST.MARY'S RUBBERS PVT. LTD c/o Mr. Manoj Zacharias Liberty Management Group Ltd 2871 Coastal Dr. Aurora, IL 60503

Re: K151114

Trade/Device Name: Medismart ( Latex Surgeon's Gloves powdered ) and Medismart + (Latex Surgeon's Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein ) Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's glove Regulatory Class: I Product Code: KGO Dated: November 7, 2015 Received: November 13, 2015

Dear Mr. 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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K151114

Device Name

Medismart (Latex Surgeon's Gloves Powdered)

Indications for Use (Describe)

A latex surgeon's gloves 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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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# Indications for Use

510(k) Number (if known) K151114

#### Device Name

Medismart + (Latex Surgeon's Gloves Powder Free, Polymer coated with protein content labeling claim of 50 µg/dm² or less per glove of extractable protein.)

#### Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR LATEX SURGEON'S GLOVES POWDERED & LATEX SURGEON'S GLOVES POWDER FREE (POLYMER COATED)

#### PAGE NO:-27-1 SECTION NO:27

# 510K SUMMARY as required by: 21CFR § 807.92 A. APPLICANT INFORMATION

K151114

| 1. | Submitter Name | ST.MARY'S RUBBERS PVT. LTD. |
|----|----------------|----------------------------------------------------------------------------------|
| | Date Submitted | December 10, 2015 |
| | Address | Koovappally P.O, Kanjirappally, Kottayam District,<br>Kerala State, India-686518 |
| | Phone | [phone] , 239857,324570 |
| | Fax | [phone] |
| | E-mail | [e-mail] |
| | Contact Person | S.Srinivasan |
| | Designation | QA Manager |
| | Contact Number | [phone] |
| | Contact Email | [e-mail] |

# B. US AGENT & CONTACT PERSON INFORMATION

| 17 | US agent & contact person name | Manoj Zacharias |
|----|--------------------------------|---------------------------------------------------------------------------|
| 18 | Address | Liberty Management Group Ltd.<br>2871, Coastal Dr. Aurora, IL-60503, USA. |
| 19 | Phone | [phone] |
| 20 | Fax | [phone] |
| 21 | E-mail | [e-mail] |

# C. DEVICE IDENTIFICATION

| Common Name | Surgeon's Gloves |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device proprietary or trade name | a. Medismart (Latex Surgeon's Gloves powdered ),<br>b. Medismart + (Latex Surgeon's Gloves Powder Free, Polymer coated with protein content labeling claim of 50 $\mu$ g/dm² or less per glove of extractable protein ) |
| Classification name | Surgeon's Gloves |
| Device Classification | I |
| 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 GLOVES POWDERED & LATEX SURGEON'S GLOVES POWDER FREE (POLYMER COATED)

#### SECTION NO:27 PAGE NO:-27-2

# D.PREDICATE DEVICE INFORMATION

| Name of device | 510k Number | 510K Owner |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|------------------------------------------------------------------------------------------------------------------------|
| SURGTEX Latex Surgeon's Gloves<br>powdered and<br>SURGTEX Latex Surgeon's Gloves<br>powder free-polymer coated with protein<br>content labeling claim of 50 $\[mu]g/dm^2$ or<br>less per glove of extractable protein | K130450 | Purna Bina SDN BHD<br>Plot 5, Jalan Mahsuri, 7.5km,<br>Jalan Mersing,<br>Kluang Industrial Area<br>Kluang, Johor 86000 |
| Latex Surgeon's Gloves (powdered and<br>Powder free) | K130301 | Elimedical Devices (Eujian) Inc.<br>1E06, Wuping Industrial Park, Wuping,<br>Fujian 364300, China |

### E. DESCRIPTION OF THE DEVICE

The proposed device, Latex Surgeon's Gloves Powdered and Latex Surgeon's Gloves Powder Free, Polymer coated with protein content labeling claim of 50 µg/dm² or less per glove of extractable protein 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, as per standard ASTM D3577-09

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

The proposed device includes Powdered and Powder Free Latex Surgeon's Gloves, and the come in different sizes ( 5½, 6, 6½, 7, 7½, 8, 8½, 9 )

All gloves share the same color, creamy white and all have beaded cuff and textured at the finger tips and palm.

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

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SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR LATEX SURGEON'S GLOVES POWDERED & LATEX SURGEON'S GLOVES POWDER FREE (POLYMER COATED)

#### SECTION NO:27 PAGE NO:-27-3

# F.INTENDED USE STATEMENT:

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

# G. NON-CLINICAL TESTING

Bench tests were conducted to verify that the proposed device met all design specifications and complies with the following standards-

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

ASTM D5151-2011:- Standard Test Method for Detection of Holes in Medical Gloves.

ASTM D6124-2011:- Standard Test Method for Residual Powder on Medical Gloves.

ASTM D5712-10:- Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method.

ASTM D6499-12:- Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and Its Products.

ASTM F1929-2004:- 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.

1SO 1137-2: 2006. Sterilization of healthcare products-Radiation-Part2: Establishing the sterilization dose.

ISO 10993-7:2008:- Biological evaluation of medical devices -- Ethylene oxide sterilization residuals

ISO 11135-1:2007:- Sterilization of healthcare products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

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SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR LATEX SURGEON'S GLOVES POWDERED & LATEX SURGEON'S GLOVES POWDER FREE (POLYMER COATED)

#### PAGE NO:-27-4 SECTION NO:27

# H. PRODUCT COMPARISON IN COMPLIANCE WITH ASTM D 3577-09 STANDARD

SIZES AVAILABLE: - 5½, 6, 6½, 7, 7½, 8, 8½, 9

| SL.NO | CRITERIA | SPECIFICATION AS<br>PER ASTM D3577-09<br>STANDARD | AVERAGE VALUE OF<br>SUBJECT DEVICE | WHETHER SUBJECT<br>DEVICE COMPLIED WITH<br>THE ASTM D3577 -09<br>STANDARD |
|-------|-------------------------------------------------------|---------------------------------------------------|------------------------------------|---------------------------------------------------------------------------|
| 1 | Length | | | |
| | Size 5½ | Min 265mm | 276 mm | Yes |
| | Size 6 | Min 265mm | 278mm | Yes |
| | Size 6½ | Min 265mm | 281mm | Yes |
| | Size 7 | Min 265mm | 281mm | Yes |
| | Size 7½ | Min 265mm | 281mm | Yes |
| | Size 8 | Min 265mm | 283mm | Yes |
| | Size 8½ | Min 265mm | 283mm | Yes |
| | Size 9 | Min 265mm | 284mm | Yes |
| 2 | Width | | | |
| | Size 5½ | 70+/-6mm | 74mm | Yes |
| | Size 6 | 76+/-6mm | 79mm | Yes |
| | Size 6½ | 83+/-6mm | 87mm | Yes |
| | Size 7 | 89+/-6mm | 93mm | Yes |
| | Size 7½ | 95+/-6mm | 98mm | Yes |
| | Size 8 | 102+/-6mm | 106mm | Yes |
| | Size 8½ | 108+/-6mm | 112mm | Yes |
| | Size 9 | 114+/-6mm | 118mm | Yes |
| 3 | Finger Thickness<br>(All sizes) | Min 0.10mm | 0.18mm | Yes |
| 4 | Palm Thickness<br>(All sizes) | Min 0.10mm | 0.16mm | Yes |
| 5 | Cuff Thickness<br>(All sizes) | Min 0.10mm | 0.12mm | Yes |
| SL.NO | CRITERIA | SPECIFICATION AS<br>PER ASTM D3577-09<br>STANDARD | AVERAGE VALUE OF<br>SUBJECT DEVICE | WHETHER SUBJECT<br>DEVICE COMPLIED WITH<br>THE ASTM D3577 -09<br>STANDARD |
| 6 | Tensile Strength | | | |
| | Before aging<br>(All sizes) | 24Mpa minimum | 28.5Mpa | Yes |
| | After aging@<br>70°±2C for<br>166±2 hr<br>(All sizes) | 18Mpa minimum | 24.2Mpa | Yes |
| 7 | Ultimate Elongation | | | |
| | Before aging<br>(All sizes) | 750% minimum | 934% | Yes |
| | After aging@<br>70°±2C for<br>166±2 hr<br>(All sizes) | 560% minimum | 758% | Yes |
| 8 | Stress at 500%<br>before aging<br>(All sizes) | 5.5 MPa Max | 3 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 |

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SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR LATEX SURGEON'S GLOVES POWDERED & LATEX SURGEON'S GLOVES POWDER FREE (POLYMER COATED)

#### SECTION NO:27 PAGE NO:-27-5

| SECTION NO:27 | PAGE NO:-27-6 |
|---------------|---------------|
|---------------|---------------|

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# SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR LATEX SURGEON'S GLOVES POWDERED & LATEX SURGEON'S GLOVES POWDER FREE (POLYMER COATED)

### I. SUBSTANTIALLY EQUIVALENT COMPARISON

#### General Characteristics Comparison a.

| Characteristic | Subject device | Predicate device<br>K130450 | Predicate device<br>K130301 | Substantially<br>Equivalent (SE)<br>or Not (NSE) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Product Code | KGO | KGO | KGO | SE |
| Regulation No. | 21 CFR 878.4460 | 21 CFR 878.4460 | 21 CFR 878.4460 | SE |
| Class | 1 | 1 | 1 | SE |
| Intended Use for<br>Latex Surgeon's<br>Gloves Powder<br>Free, Polymer<br>coated with<br>protein content<br>labeling claim of<br>50 µg/dm² or less<br>per glove of<br>extractable<br>protein. | A latex surgeon's gloves is a device<br>made of natural rubber intended to<br>be worn by operating room<br>personnel to protect a surgical<br>wound from contamination. | This Surgeons<br>glove is a device<br>made of natural<br>rubber intended<br>to be worn by<br>operating room<br>personnel to<br>protect a surgical<br>wound from<br>contamination. | - | Substantially<br>equivalent |
| Intended Use<br>Latex Surgeon's<br>Gloves Powdered | A latex surgeon's gloves is a device<br>made of natural rubber intended to<br>be worn by operating room<br>personnel to protect a surgical<br>wound from contamination. | This Surgeons<br>glove is a device<br>made of natural<br>rubber intended<br>to be worn by<br>operating room<br>personnel to<br>protect a surgical<br>wound from contamination. | A latex surgeons<br>glove is a device<br>made of natural<br>rubber intended<br>to be worn by<br>operating room<br>personnel to<br>protect a surgical<br>wound from contamination | Substantially<br>equivalent |
| Powdered or<br>Powder free | Powdered, and powered free | Powdered, and<br>powered free | Powdered, and<br>powered free | SE |
| Classification per<br>ASTMD3577-99 | Type I - gloves compounded<br>primarily from natural 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 | SE |
| Sterilization | ETO SAL- 10-6 OR<br>Radiation SAL- 10-6 | Radiation SAL:<br>10-6 | Radiation SAL:<br>10-6 | SE |
| Label and<br>Labeling | Meet FDA's Requirements | Meet FDA's<br>Requirements | Meet FDA's<br>Requirements | SE |
| Special label<br>claim | Protein content labeling claim of 50<br>µg/dm²<br>or less per glove of<br>extractable protein for Latex<br>Surgeon's Gloves Powder Free,<br>Polymer coated | Same | - | SE |
| Type of use | Over the counter use | Over the counter<br>use | Over the counter<br>use | SE |

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## SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR LATEX SURGEON'S GLOVES POWDERED & LATEX SURGEON'S GLOVES POWDER FREE (POLYMER COATED)

#### PAGE NO:-27-7 SECTION NO:27

### b. Technological Characteristics Comparison

| Characteristics | Acceptance criteria of the standard | | Whether the subject<br>device met the<br>acceptance criteria of<br>the standard | |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------|
| | Subject device | Predicate device<br>K130450 | Predicate device<br>K130301 | |
| Dimensions | ASTM D3577-09<br>(published date<br>02/01/2009) | ASTM D3577-09 | ASTM D3577-09 | Yes |
| Physical<br>Properties | ASTM D3577-09<br>(published date<br>02/01/2009) | ASTM D3577-09 | ASTM D3577-09 | Yes |
| Freedom from<br>Holes | ASTM D3577 and<br>ASTM D5151,(published<br>date 08/20/2012) | ASTM D3577 and<br>ASTM D5151 | ASTM D3577 and<br>ASTM D5151 | Yes |
| Powder Content<br>for powdered<br>glove | ASTM D3577 and ASTM<br>D6124,(published date<br>08/20/2012) (Max 15 mg/<br>dm² )<br>Our glove has 10mg/dm²<br>on average. | ASTM D3577 and<br>ASTM D6124 | ASTM D3577 and<br>ASTM D6124 | Yes |
| Powder Content<br>for powder free<br>glove | ASTM D3577 and ASTM<br>D6124,(published date<br>08/20/2012)<br>Powder content < 2<br>mg/Glove | ASTM D3577 and<br>ASTM D6124,<br>Powder content < 2<br>mg/Glove | ASTM D3577 and<br>ASTM D6124,<br>Powder content < 2<br>mg/Glove | Yes |
| Protein Content | ASTM D3577, ASTM<br>D5712-10 and *ASTM D<br>6499<br>(published date<br>02/01/2009)<br>Our glove has Protein<br>Content less than 50<br>µg/dm² | ASTM D3577,<br>ASTM D5712-10 and<br>ASTM D6499 | ASTM D3577,<br>ASTM D5712-10<br>and ASTM D6499 | Yes |
| Biocompatibility<br>Skin sensitization<br>Skin irritation | ISO 10993-10<br>Non- sensitizer under the<br>conditions of the studies.<br>Non -irritant under the<br>conditions of the studies. | ISO 10993-10 | ISO 10993-10 | Yes,<br>Non-Sensitizer and<br>Non- irritant |

*Conformance with ASTM D 6499 was an extra step to corroborate the claim 50 µg/dm² or less / glove

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### SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR LATEX SURGEON'S GLOVES POWDERED & LATEX SURGEON'S GLOVES POWDER FREE (POLYMER COATED)

#### SECTION NO:27 PAGE NO:-27-8

### Substantial Equivalence Discussion

The difference with predicate device is in the sterilization method. The proposed device is sterilized by ETO or Radiation method. Both give a final SAL of 106 which meets the acceptance level for sterilization.

Clinical data was not required for this submission.

# Substantial Equivalence Conclusions

The conclusion drawn from the non-clinical tests demonstrate that the devices Medismart (Latex Surgeon's Gloves Powdered) and Medismart + (Latex Surgeon's Gloves Powder Free, Polymer coated with protein content labeling claim of 50 µg/dm² or less per glove of extractable protein), are as safe and as effective and perform as well as the legally marketed predicate devices SURGTEX Latex Surgeon's Gloves powdered and SURGTEX Latex Surgeon's Gloves powderfree-polymer coated with protein content labeling claim of 50 µg/dm² or less per glove of extractable protein (K130450) and Latex Surgeon's Gloves (powdered and Powder free (K130301); therefore, we conclude that the subject device is substantially equivalent to the predicate devices.