(228 days)
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.
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.
This appears to be a 510(k) summary for a medical device (latex surgeon's gloves), not a study specifically designed to assess an AI/ML device or its performance against acceptance criteria in the way typically expected for such technologies. Therefore, many of the requested elements (like sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable or not detailed in this document.
However, I can extract the acceptance criteria and demonstrated performance for the physical and biological characteristics of the surgeon's gloves, as described in the "Product Comparison in Compliance with ASTM D 3577-09 Standard" and "Technological Characteristics Comparison" sections.
Here's the information formatted according to your request, with notes indicating where the requested AI-specific information is not present in this document:
1. Table of Acceptance Criteria and Reported Device Performance
| SL.NO | CRITERIA | SPECIFICATION AS PER ASTM D3577-09 STANDARD / Acceptance Criteria | AVERAGE VALUE OF SUBJECT DEVICE / Reported Device Performance |
|---|---|---|---|
| 1 | Length | ||
| Size 5½ | Min 265mm | 276 mm | |
| Size 6 | Min 265mm | 278mm | |
| Size 6½ | Min 265mm | 281mm | |
| Size 7 | Min 265mm | 281mm | |
| Size 7½ | Min 265mm | 281mm | |
| Size 8 | Min 265mm | 283mm | |
| Size 8½ | Min 265mm | 283mm | |
| Size 9 | Min 265mm | 284mm | |
| 2 | Width | ||
| Size 5½ | 70+/-6mm | 74mm | |
| Size 6 | 76+/-6mm | 79mm | |
| Size 6½ | 83+/-6mm | 87mm | |
| Size 7 | 89+/-6mm | 93mm | |
| Size 7½ | 95+/-6mm | 98mm | |
| Size 8 | 102+/-6mm | 106mm | |
| Size 8½ | 108+/-6mm | 112mm | |
| Size 9 | 114+/-6mm | 118mm | |
| 3 | Finger Thickness (All sizes) | Min 0.10mm | 0.18mm |
| 4 | Palm Thickness (All sizes) | Min 0.10mm | 0.16mm |
| 5 | Cuff Thickness (All sizes) | Min 0.10mm | 0.12mm |
| 6 | Tensile Strength | ||
| Before aging (All sizes) | 24Mpa minimum | 28.5Mpa | |
| After aging @ 70°±2C for 166±2 hr (All sizes) | 18Mpa minimum | 24.2Mpa | |
| 7 | Ultimate Elongation | ||
| Before aging (All sizes) | 750% minimum | 934% | |
| After aging @ 70°±2C for 166±2 hr (All sizes) | 560% minimum | 758% | |
| 8 | Stress at 500% before aging (All sizes) | 5.5 MPa Max | 3 Mpa |
| 9 | Pinhole AQL | ||
| Before aging (All sizes) | Max 1.5 | 1.0 | |
| After aging @ 70°C for 7 days (All sizes) | Max 1.5 | 1.0 | |
| 10 | Freedom from Holes | Complies with ASTM D3577 and ASTM D5151 | Yes (device met acceptance criteria) |
| 11 | Powder Content for powdered glove | ASTM D3577 and ASTM D6124 (Max 15 mg/dm²) | 10 mg/dm² on average (device met acceptance criteria) |
| 12 | Powder Content for powder free glove | ASTM D3577 and ASTM D6124 (Powder content < 2 mg/Glove) | Yes (device met acceptance criteria - implicitly < 2 mg/Glove, or else the text would specify) |
| 13 | Protein Content (for Latex Surgeon's Gloves Powder Free, Polymer coated) | ASTM D3577, ASTM D5712-10 and ASTM D6499 (Protein Content less than 50 µg/dm²) | Less than 50 µg/dm² (device met acceptance criteria) |
| 14 | Biocompatibility - Skin sensitization | ISO 10993-10: Non-sensitizer under the conditions of the studies | Non-Sensitizer (device met acceptance criteria) |
| 15 | Biocompatibility - Skin irritation | ISO 10993-10: Non-irritant under the conditions of the studies | Non-Irritant (device met acceptance criteria) |
| 16 | Sterilization | ETO SAL- 10⁻⁶ OR Radiation SAL- 10⁻⁶ (meets acceptance level for sterilization) | ETO SAL- 10⁻⁶ OR Radiation SAL- 10⁻⁶ (device met acceptance criteria) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document does not specify exact sample sizes for each test conducted (e.g., how many gloves were tested for length, pinholes, tensile strength, etc.). It refers to meeting the standards like ASTM D3577-09, which would define the statistical sampling plans.
- Data Provenance: The submitting company is ST.MARY'S RUBBERS PVT. LTD. from Kottayam District, Kerala State, India. The tests were presumably conducted internally or by a contracted lab, but the specific location of data generation for these bench tests is not explicitly stated. The nature of these tests (physical and chemical properties) means there isn't "retrospective" or "prospective" data in the clinical sense. It's a characterization of manufactured product batches.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not applicable for this type of device and study. The "ground truth" for the physical and chemical properties of the gloves is established by objective measurements against international standards (ASTM, ISO), not by expert consensus or interpretation of medical images/data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable for this type of device and study. Adjudication methods are typically used in clinical or image-based studies where expert interpretation can vary. The tests here are objective measurements.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This information is not applicable for this type of device and study. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable for this type of device and study. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for these tests is defined by the quantitative specifications and methodologies outlined in the referenced international standards (ASTM D3577-09, ASTM D5151-2011, ASTM D6124-2011, ASTM D5712-10, ASTM D6499-12, ASTM F1929-2004, ISO 10993-10:2010, ISO 1137-2:2006, ISO 10993-7:2008, ISO 11135-1:2007). These standards provide the validated methods and acceptable limits for measuring physical, mechanical, and biological properties.
8. The sample size for the training set
- This information is not applicable for this type of device and study. This is not an AI/ML device, and there is no "training set" in the machine learning sense. The manufacturing process is controlled to meet the specifications, and testing is performed on manufactured lots.
9. How the ground truth for the training set was established
- This information is not applicable for this type of device and study. See point 8.
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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.
{1}------------------------------------------------
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 PRAStaff@fda.hhs.gov
"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."
{3}------------------------------------------------
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 PRAStaff@fda.hhs.gov
"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."
{4}------------------------------------------------
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
| 1. | Submitter Name | ST.MARY'S RUBBERS PVT. LTD. |
|---|---|---|
| Date Submitted | December 10, 2015 | |
| Address | Koovappally P.O, Kanjirappally, Kottayam District,Kerala State, India-686518 | |
| Phone | +91 4828 251533 , 239857,324570 | |
| Fax | +91 4828 251353 | |
| info@stmarysrubbers.com | ||
| Contact Person | S.Srinivasan | |
| Designation | QA Manager | |
| Contact Number | +91 9497244270 | |
| Contact Email | qa@stmarysrubbers.com |
B. US AGENT & CONTACT PERSON INFORMATION
| 17 | US agent & contact person name | Manoj Zacharias |
|---|---|---|
| 18 | Address | Liberty Management Group Ltd.2871, Coastal Dr. Aurora, IL-60503, USA. |
| 19 | Phone | (630) 270-2921 |
| 20 | Fax | (815) 986-2632 |
| 21 | manoj@libertymanagement.us |
C. DEVICE IDENTIFICATION
| Common Name | Surgeon's Gloves |
|---|---|
| Device proprietary or trade name | a. Medismart (Latex Surgeon's Gloves powdered ),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 Glovespowdered andSURGTEX Latex Surgeon's Glovespowder free-polymer coated with proteincontent labeling claim of 50 $[mu]g/dm^2$ orless per glove of extractable protein | K130450 | Purna Bina SDN BHDPlot 5, Jalan Mahsuri, 7.5km,Jalan Mersing,Kluang Industrial AreaKluang, Johor 86000 |
| Latex Surgeon's Gloves (powdered andPowder free) | K130301 | Elimedical Devices (Eujian) Inc.1E06, Wuping Industrial Park, Wuping,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 ASPER ASTM D3577-09STANDARD | AVERAGE VALUE OFSUBJECT DEVICE | WHETHER SUBJECTDEVICE COMPLIED WITHTHE ASTM D3577 -09STANDARD |
|---|---|---|---|---|
| 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(All sizes) | Min 0.10mm | 0.18mm | Yes |
| 4 | Palm Thickness(All sizes) | Min 0.10mm | 0.16mm | Yes |
| 5 | Cuff Thickness(All sizes) | Min 0.10mm | 0.12mm | Yes |
| SL.NO | CRITERIA | SPECIFICATION ASPER ASTM D3577-09STANDARD | AVERAGE VALUE OFSUBJECT DEVICE | WHETHER SUBJECTDEVICE COMPLIED WITHTHE ASTM D3577 -09STANDARD |
| 6 | Tensile Strength | |||
| Before aging(All sizes) | 24Mpa minimum | 28.5Mpa | Yes | |
| After aging@70°±2C for166±2 hr(All sizes) | 18Mpa minimum | 24.2Mpa | Yes | |
| 7 | Ultimate Elongation | |||
| Before aging(All sizes) | 750% minimum | 934% | Yes | |
| After aging@70°±2C for166±2 hr(All sizes) | 560% minimum | 758% | Yes | |
| 8 | Stress at 500%before aging(All sizes) | 5.5 MPa Max | 3 Mpa | Yes |
| 9 | Pinhole AQL | |||
| Before aging(All sizes) | Max 1.5 | 1.0 | Yes | |
| After aging@70°C for 7 days(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 deviceK130450 | Predicate deviceK130301 | SubstantiallyEquivalent (SE)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 forLatex Surgeon'sGloves PowderFree, Polymercoated withprotein contentlabeling claim of50 µg/dm² or lessper glove ofextractableprotein. | A latex surgeon's gloves is a devicemade of natural rubber intended tobe worn by operating roompersonnel to protect a surgicalwound from contamination. | This Surgeonsglove is a devicemade of naturalrubber intendedto be worn byoperating roompersonnel toprotect a surgicalwound fromcontamination. | - | Substantiallyequivalent |
| Intended UseLatex Surgeon'sGloves Powdered | A latex surgeon's gloves is a devicemade of natural rubber intended tobe worn by operating roompersonnel to protect a surgicalwound from contamination. | This Surgeonsglove is a devicemade of naturalrubber intendedto be worn byoperating roompersonnel toprotect a surgicalwound from contamination. | A latex surgeonsglove is a devicemade of naturalrubber intendedto be worn byoperating roompersonnel toprotect a surgicalwound from contamination | Substantiallyequivalent |
| Powdered orPowder free | Powdered, and powered free | Powdered, andpowered free | Powdered, andpowered free | SE |
| Classification perASTMD3577-99 | Type I - gloves compoundedprimarily from natural rubber latex | Type I - glovescompoundedprimarily fromnatural rubberlatex | Type I - glovescompoundedprimarily fromnatural rubberlatex | SE |
| Sterilization | ETO SAL- 10-6 ORRadiation SAL- 10-6 | Radiation SAL:10-6 | Radiation SAL:10-6 | SE |
| Label andLabeling | Meet FDA's Requirements | Meet FDA'sRequirements | Meet FDA'sRequirements | SE |
| Special labelclaim | Protein content labeling claim of 50µg/dm²or less per glove ofextractable protein for LatexSurgeon's Gloves Powder Free,Polymer coated | Same | - | SE |
| Type of use | Over the counter use | Over the counteruse | Over the counteruse | 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 subjectdevice met theacceptance criteria ofthe standard | ||
|---|---|---|---|---|
| Subject device | Predicate deviceK130450 | Predicate deviceK130301 | ||
| Dimensions | ASTM D3577-09(published date02/01/2009) | ASTM D3577-09 | ASTM D3577-09 | Yes |
| PhysicalProperties | ASTM D3577-09(published date02/01/2009) | ASTM D3577-09 | ASTM D3577-09 | Yes |
| Freedom fromHoles | ASTM D3577 andASTM D5151,(publisheddate 08/20/2012) | ASTM D3577 andASTM D5151 | ASTM D3577 andASTM D5151 | Yes |
| Powder Contentfor powderedglove | ASTM D3577 and ASTMD6124,(published date08/20/2012) (Max 15 mg/dm² )Our glove has 10mg/dm²on average. | ASTM D3577 andASTM D6124 | ASTM D3577 andASTM D6124 | Yes |
| Powder Contentfor powder freeglove | ASTM D3577 and ASTMD6124,(published date08/20/2012)Powder content < 2mg/Glove | ASTM D3577 andASTM D6124,Powder content < 2mg/Glove | ASTM D3577 andASTM D6124,Powder content < 2mg/Glove | Yes |
| Protein Content | ASTM D3577, ASTMD5712-10 and *ASTM D6499(published date02/01/2009)Our glove has ProteinContent less than 50µg/dm² | ASTM D3577,ASTM D5712-10 andASTM D6499 | ASTM D3577,ASTM D5712-10and ASTM D6499 | Yes |
| BiocompatibilitySkin sensitizationSkin irritation | ISO 10993-10Non- sensitizer under theconditions of the studies.Non -irritant under theconditions of the studies. | ISO 10993-10 | ISO 10993-10 | Yes,Non-Sensitizer andNon- 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.
§ 878.4460 Non-powdered surgeon's glove.
(a)
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.(b)
Classification. Class I (general controls).