(228 days)
Not Found
No
The device description and performance studies focus on the physical properties and material compliance of surgical gloves, with no mention of AI or ML.
No
The device is a surgeon's glove intended to protect a surgical wound from contamination, not to treat or prevent a disease or condition.
No
The device is a surgeon's glove, intended to protect a surgical wound from contamination, not to diagnose a medical condition.
No
The device description clearly states it is a physical product (gloves made of natural rubber latex) and the performance studies involve bench testing of physical properties. There is no mention of software as the primary component or function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "to be worn by operating room personnel to protect a surgical wound from contamination." This is a barrier function for protection during a medical procedure.
- Device Description: The description focuses on the physical properties of the glove (material, size, sterilization, etc.) and its function as a protective barrier.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This glove does not perform any such analysis of biological specimens.
The information provided consistently describes a medical device used for physical protection during surgery, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
KGO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
ISO 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
Key Results: The subject device complied with the ASTM D3577-09 standard for Length, Width, Finger Thickness, Palm Thickness, Cuff Thickness, Tensile Strength, Ultimate Elongation, Stress at 500% before aging, and Pinhole AQL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Length (Min 265mm), Width (Size 5½: 70+/-6mm, Size 6: 76+/-6mm, Size 6½: 83+/-6mm, Size 7: 89+/-6mm, Size 7½: 95+/-6mm, Size 8: 102+/-6mm, Size 8½: 108+/-6mm, Size 9: 114+/-6mm), Finger Thickness (Min 0.10mm), Palm Thickness (Min 0.10mm), Cuff Thickness (Min 0.10mm), Tensile Strength (Before aging: 24Mpa minimum, After aging: 18Mpa minimum), Ultimate Elongation (Before aging: 750% minimum, After aging: 560% minimum), Stress at 500% before aging (5.5 MPa Max), Pinhole AQL (Before aging: Max 1.5, After aging: Max 1.5).
Powder Content for powdered glove: Our glove has 10mg/dm² on average (Max 15 mg/dm²).
Powder Content for powder free glove: Powder content
§ 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).
0
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
2
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 |
5
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 | ||
| powdered and | ||
| SURGTEX Latex Surgeon's Gloves | ||
| powder free-polymer coated with protein | ||
| content labeling claim of 50 $[mu]g/dm^2$ or | ||
| less per glove of extractable protein | K130450 | Purna Bina SDN BHD |
| Plot 5, Jalan Mahsuri, 7.5km, | ||
| Jalan Mersing, | ||
| Kluang Industrial Area | ||
| Kluang, Johor 86000 | ||
| Latex Surgeon's Gloves (powdered and | ||
| Powder 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.
6
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
7
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
PER ASTM D3577-09
STANDARD | AVERAGE VALUE OF
SUBJECT DEVICE | WHETHER SUBJECT
DEVICE COMPLIED WITH
THE ASTM D3577 -09
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
(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 AS
PER ASTM D3577-09
STANDARD | AVERAGE VALUE OF
SUBJECT DEVICE | WHETHER SUBJECT
DEVICE COMPLIED WITH
THE ASTM D3577 -09
STANDARD |
| 6 | Tensile Strength | | | |
| | Before aging
(All sizes) | 24Mpa minimum | 28.5Mpa | Yes |
| | After aging@
70°±2C for
166±2 hr
(All sizes) | 18Mpa minimum | 24.2Mpa | Yes |
| 7 | Ultimate Elongation | | | |
| | Before aging
(All sizes) | 750% minimum | 934% | Yes |
| | After aging@
70°±2C for
166±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 |
8
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 |
|---|---|
| --------------- | --------------- |
9
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
K130450 | Predicate device
K130301 | Substantially
Equivalent (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 for
Latex Surgeon's
Gloves Powder
Free, Polymer
coated with
protein content
labeling claim of
50 µg/dm² or less
per glove of
extractable
protein. | 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. | This Surgeons
glove is a device
made of natural
rubber intended
to be worn by
operating room
personnel to
protect a surgical
wound from
contamination. | - | Substantially
equivalent |
| Intended Use
Latex Surgeon's
Gloves Powdered | 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. | This Surgeons
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 surgeons
glove is a device
made of natural
rubber intended
to be worn by
operating room
personnel to
protect a surgical
wound from contamination | Substantially
equivalent |
| Powdered or
Powder free | Powdered, and powered free | Powdered, and
powered free | Powdered, and
powered free | SE |
| Classification per
ASTMD3577-99 | Type I - gloves compounded
primarily from natural rubber latex | Type I - gloves
compounded
primarily from
natural rubber
latex | Type I - gloves
compounded
primarily from
natural rubber
latex | SE |
| Sterilization | ETO SAL- 10-6 OR
Radiation SAL- 10-6 | Radiation SAL:
10-6 | Radiation SAL:
10-6 | SE |
| Label and
Labeling | Meet FDA's Requirements | Meet FDA's
Requirements | Meet FDA's
Requirements | SE |
| Special label
claim | Protein content labeling claim of 50
µg/dm²
or less per glove of
extractable protein for Latex
Surgeon's Gloves Powder Free,
Polymer coated | Same | - | SE |
| Type of use | Over the counter use | Over the counter
use | Over the counter
use | SE |
10
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
device met the
acceptance criteria of
the standard | |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------|
| | Subject device | Predicate device
K130450 | Predicate device
K130301 | |
| Dimensions | ASTM D3577-09
(published date
02/01/2009) | ASTM D3577-09 | ASTM D3577-09 | Yes |
| Physical
Properties | ASTM D3577-09
(published date
02/01/2009) | ASTM D3577-09 | ASTM D3577-09 | Yes |
| Freedom from
Holes | ASTM D3577 and
ASTM D5151,(published
date 08/20/2012) | ASTM D3577 and
ASTM D5151 | ASTM D3577 and
ASTM D5151 | Yes |
| Powder Content
for powdered
glove | ASTM D3577 and ASTM
D6124,(published date
08/20/2012) (Max 15 mg/
dm² )
Our glove has 10mg/dm²
on average. | ASTM D3577 and
ASTM D6124 | ASTM D3577 and
ASTM D6124 | Yes |
| Powder Content
for powder free
glove | ASTM D3577 and ASTM
D6124,(published date
08/20/2012)
Powder content