(217 days)
Not Found
No
The device description and performance studies focus on the physical properties, sterility, and biocompatibility of surgical gloves, with no mention of AI or ML.
No.
A surgical glove is a barrier device primarily intended for protection, not for treating or preventing a disease or condition, or affecting the structure or function of the body.
No
Explanation: The device is a sterile latex surgical glove, which is intended to protect a surgical wound from contamination, not to diagnose a condition or disease.
No
The device description clearly states it is a physical product made of natural rubber latex (surgical gloves) and details its material properties, manufacturing process, and sterilization methods. There is no mention of software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: An In Vitro Diagnostic device is a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Intended Use: The intended use of this device is clearly stated as "to be worn by operating room personnel to protect a surgical wound from contamination." This is a barrier device used on the body (or rather, on the hands of the user) to prevent the transfer of contaminants.
- Device Description: The description focuses on the physical properties and materials of the glove, its sterilization method, and its intended use as a protective barrier. There is no mention of analyzing biological samples or performing diagnostic tests.
- Lack of IVD-related information: The document does not contain any information typically associated with IVDs, such as:
- Analysis of biological samples
- Detection of analytes (e.g., proteins, DNA, antibodies)
- Diagnostic claims
- Performance metrics like sensitivity, specificity, or AUC (which are relevant to diagnostic accuracy)
This device is a surgical glove, which is a type of medical device used for protection and barrier purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
A Sterile Latex Surgical Gloves Powder Free 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, Sterile Latex Surgical 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 from contamination.
The proposed device is made of natural rubber latex, as per standard ASTM D35 77 -09(2015), Standard Specification for Rubber Surgical Gloves.
The classification is: Type I - gloves compounded primarily from natural rubber latex.
The proposed device is Sterile Latex Surgical Gloves Powder Free, and variants of different sizes.
All variants share the same natural color (No color additive is added).
The proposed device is sterilized using Gamma and ETO method to achieve the Sterility Assurance Level (SAL) of 10 and place in a sterility maintained package to ensure a shelf life of 5years.
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. The test results demonstrated that the proposed device complies with the following standards:
ASTM D3577-09(15):- Standard Specification for Rubber Surgical Gloves.
ASTM D 5151-06 (2015):- Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6124-06 (2017):- Standard Test Method for Residual Powder on Medical Gloves.
ASTM D5712-15:-Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method.
ASTM D6499-18:-Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and Its Products.
ASTM F1929-2015:- 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 10993-5:2009(E) Biological Evaluation of Medical Devices - Part 5-Tests for in vitro Cytotoxicity
ISO 10993-11:2017(E) Biological Evaluation of Medical Devices - Part 11- Tests for Systemic Toxicity and Biological Tests
USP 41 Pyrogen Test
ISO 11137-1-2006/ (R) 2010 - validation of sterilization process
ISO 11137-2:2013, sterilization of health care products - radiation - part 2: Establishing the sterilization dose
USP Bacterial Endotoxin Test
The non-clinical tests showed the device complied with the specifications for:
Length (various sizes)
Width (various sizes)
Finger Thickness
Palm Thickness
Cuff Thickness
Tensile Strength (Before and After aging)
Ultimate Elongation (Before and After aging)
Stress at 500% before ageing
Pinhole AQL (Before and After aging)
Powder residue for powder free glove
Protein Content
Biocompatibility tests for Skin Irritation & Skin Sensitization (Non-irritant and Non-Sensitizer)
In vitro cytotoxicity (Cytotoxic)
Material Mediated pyrogenicity (Non pyrogenic)
Acute Systemic Toxicity (device extracts do not pose a systemic toxicity concern)
Bacterial Endotoxin (
§ 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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 3, 2021
MRK Healthcare Pvt Ltd % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, Illinois 60504
Re: K210969
Trade / Device Name: Nulife / Sterile Latex Surgical Gloves Powder Free Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO Dated: September 28, 2021 Received: October 8, 2021
Dear Manoj Zacharias:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
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 (QS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Clarence Murray, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210969
Device Name
Sterile Latex Surgical Gloves powder free
Indications for Use (Describe)
A Sterile Latex Surgical Gloves Powder Free 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)
| Residential Use: For 1-4 STR/MTA Subject Sites |
|---|
| Group Tier Exception: 1-4 STR/MTA Subject Sites |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510K SUMMARY K210969 As required by: 21CFR § 807.92
A. APPLICANT INFORMATION
| 1. | Submitter Name | MRK Healthcare Pvt Ltd |
|---|---|---|
| 2 | Date Submitted | 26 OCT 2021 |
| 3 | Activity | Manufacturer |
| 4 | Address | S.No.153/P&310,Panch, Pippal,Hansapur, |
| Runi, Unjha-Patan Road, Patan-384265, Gujarat. India. | ||
| 5 | Phone | +91 2766 297206 / 297207 |
| 6 | Fax | ------- |
| 7 | regulatorymrk@gmail.com | |
| 8 | Contact Person | Anil R Dave |
| 9 | Designation | Regulatory Assurance Officer |
| 10 | Contact Number | +91 2766 297206 / 297207 |
| 11 | Contact Email | regulatorymrk@gmail.com |
B.US AGENT & CONTACT PERSON INFORMATION
| 12 | US agent &
contact person name | Manoj Zacharias |
|----|-----------------------------------|-----------------------------------------------------------------------------------|
| 13 | Address | Liberty Management Group Ltd.
75 Executive Dr. STE 114, Aurora, IL-60504, USA. |
| 14 | Phone | (630) 270-2921 |
| 15 | Fax | (815) 986-2632 |
| 16 | E-mail | manoj@libertymanagement.us |
C. DEVICE IDENTIFICATION
| 17 | Common Name | Surgical Gloves |
|---|---|---|
| 18 | Device Name | Sterile Latex Surgical Gloves Powder Free |
| 19 | Product proprietary or | |
| trade name | Nulife | |
| 20 | Classification name | Surgeon's Gloves |
| 21 | Device Classification | 1 |
| 22 | Product Code | KGO |
| 23 | Regulation Number | 21 CFR 878.4460 |
| 24 | Review Panel | General Hospital and Plastic Surgery |
4
D.PREDICATE DEVICE INFORMATION
| Description | Name of device | 510k
Number | 510K Owner |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate
device | JR Medic Latex Surgeon's Gloves
Sterile Powder Free with protein
content labeling claim of 50 µg/
dm² or less per glove of
extractable protein | K192328 | JR Engineering & Medical
Technologies (M) SDN.
BHD.
Lot 8 &10, Jalan Zurah 3
& Lot 1&3, Jalan Zurah
3A/1, Pusat Perindustrian
2, 44200 Rasa, Hulu
Selangor, Selangor Darul
Ehsan, Malaysia. |
E. DESCRIPTION OF THE DEVICE
The proposed device, Sterile Latex Surgical 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 from contamination.
The proposed device is made of natural rubber latex, as per standard ASTM D35 77 -09(2015), Standard Specification for Rubber Surgical Gloves.
The classification is: Type I - gloves compounded primarily from natural rubber latex.
The proposed device is Sterile Latex Surgical Gloves Powder Free, and variants of different sizes.
All variants share the same natural color (No color additive is added).
The proposed device is sterilized using Gamma and ETO method to achieve the Sterility Assurance Level (SAL) of 10 and place in a sterility maintained package to ensure a shelf life of 5years.
F. INTENDED USE/INDICATION FOR USE:
A Sterile Latex Surgical Gloves Powder Free is a device made of natural rubber intended to be
worn by operating room personnel to protect a surgical wound from contamination.
5
G. NON-CLINICAL TEST STANDARDS
Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
ASTM D3577-09(15):- Standard Specification for Rubber Surgical Gloves.
ASTM D 5151-06 (2015):- Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6124-06 (2017):- Standard Test Method for Residual Powder on Medical Gloves.
ASTM D5712-15:-Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method.
ASTM D6499-18:-Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and Its Products.
ASTM F1929-2015:- 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 10993-5:2009(E) Biological Evaluation of Medical Devices - Part 5-Tests for in vitro Cytotoxicity
ISO 10993-11:2017(E) Biological Evaluation of Medical Devices - Part 11- Tests for Systemic Toxicity and Biological Tests
USP 41 Pyrogen Test
ISO 11137-1-2006/ (R) 2010 - validation of sterilization process
ISO 11137-2:2013, sterilization of health care products - radiation - part 2: Establishing the sterilization dose
USP Bacterial Endotoxin Test
6
H. SUMMARY OF NON-CLINICAL PERFORMANCE TESTS ACCORDING TO ASTM D3577-09, STANDARD SPECIFICATION FOR RUBBER SURGICAL GLOVES
| Sl.No | Criteria | Specification as per
ASTMD3577-
09,Standard
Specification for
Rubber Surgical
Gloves | Average value of
subject device | Whether subject
device complied
with
theASTMD3577 -
09,Standard
Specification for
Rubber Surgical
Gloves |
|-------|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| 1 | Length | | | |
| | Size 5.5 | Min 245mm | 483mm | Yes |
| | Size 6 | Min 265mm | 485mm | Yes |
| | Size 6.5 | Min 265mm | 486mm | Yes |
| | Size 7 | Min 265mm | 486mm | Yes |
| | Size 7.5 | Min 265mm | 486mm | Yes |
| | Size 8 | Min 265mm | 487mm | Yes |
| | Size 8.5 | Min 265mm | 487mm | Yes |
| | Size 9 | Min 265mm | 487mm | Yes |
| 2 | Width | | | |
| | Size 5.5 | 70+/-6mm | 71mm | Yes |
| | Size 6 | 76+/-6mm | 74mm | Yes |
| | Size 6.5 | 83+/-6mm | 88mm | Yes |
| | Size 7 | 89+/-6mm | 92mm | Yes |
| | Size 7.5 | 95+/-6mm | 98mm | Yes |
| | Size 8 | 102+/-6mm | 103mm | Yes |
| | Size 8.5 | 108+/-6mm | 110mm | Yes |
| | Size 9 | 114+/-6mm | 116mm | Yes |
| 3 | Finger
Thickness | Min 0.10mm | 0.32mm | Yes |
| | (All sizes) | | | |
| 4 | Palm Thickness | Min 0.10mm | 0.20mm | Yes |
| | (All sizes) | | | |
| 5 | Cuff Thickness | Min 0.10mm | 0.15mm | Yes |
| | (All sizes) | | | |
| SL.NO | CRITERIA | Specification as per
ASTMD3577-09
Standard
Specification for
Rubber Surgical
Gloves | Average Value
of Subject
Device | Whether Subject
Device Complied with
the ASTMD3577 -09
Standard
Specification for
Rubber Surgical
Gloves |
| 6 | Tensile Strength | | | |
| | Before aging
(All sizes) | 24Mpa minimum | 28.32Mpa | Yes |
| | After aging@
70°±2C for
166±2 hr
(All sizes) | 18Mpa minimum | 23.21Mpa | Yes |
| 7 | Ultimate Elongation | | | |
| | Before aging
(All sizes) | 750% minimum | 869% | Yes |
| | After aging@
70°±2C for
166±2 hr
(All sizes) | 560% minimum | 730% | Yes |
| 8 | Stress at 500%
before ageing
(All sizes) | 5.5 MPa Max | 5.1Mpa | 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 |
SIZES AVAILABLE: -5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9
7
8
I. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS BETWEEN THE
PREDICATE AND SUBJECT DEVICES
a. General Characteristics Comparison
| Characteristic | Subject device
K210969 | Predicate device
K192328 | Remarks | |
|-----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Product Code | KGO | KGO | Same | |
| Regulation No. | 21 CFR 878.4460 | 21 CFR 878.4460 | Same | |
| Class | 1 | 1 | Same | |
| Intended Use/
Indications of Use | A Sterile Latex Surgical
Gloves Powder Free is a
device made of natural
rubber intended to be worn
by operating room personnel
to protect a surgical wound
from contamination. | A latex surgeon's glove is a
device made of natural
rubber intended to be worn
by operating room
personnel to protect a
surgical wound from
contamination. | Similar | |
| Powdered or Powder
free | Powder free | Powder free | Same | |
| Classification as per
ASTMD3577-09,
Standard Specification
for Rubber Surgical
Gloves | Type I - gloves compounded
primarily from natural
rubber latex | Type I - gloves
compounded primarily
from natural rubber latex | Same | |
| Sterilization | ETO or Radiation,
SAL- 10-6 | Radiation,
SAL- 10-6 | Similar | |
| Label and Labeling | Meet FDA's label
Requirements | Meet FDA's label
Requirements | Same | |
| Special label claim | Protein content labeling
claim of 50µg/dm² or less per
glove of extractable protein
for Latex Surgeon's Gloves
Powder Free. | Protein content labeling
claim of 50µg/dm² or less
per glove of extractable
protein for Latex Surgeon's
Gloves Powder Free. | Same | |
| Type of use | Over the counter use | Over the counter use | Same | |
| Characteristics | Acceptance criteria of the standard | | Remarks | |
| | Subject device
K210969 | Predicate device
K192328 | | |
| Dimensions
Length:- Min
265 mm | 486 mm | 300 mm | Similar
Meets ASTM D3577-
09(Reapproved 2015), Standard
Specification for Rubber Surgical
Gloves | |
| Size
5.5(70+/-6mm)
6.0(76+/-6mm)
6.5(83+/-6mm)
7.0(89+/-6mm)
7.5(95+/-6mm)
8.0(102+/6mm)
8.5(108+/6mm)
9.0 (114+/6mm) | 71mm
74mm
88mm
92mm
98mm
103mm
110mm
116mm | -
78mm
85mm
88mm
97mm
103mm
110mm
116mm | Similar
Meets ASTM D3577-
09(Reapproved 2015), Standard
Specification for Rubber Surgical
Gloves | |
| Cuff, Palm,
Finger Tip Min
0.10 mm | Cuff-
0.15mm
Palm-0.20mm
Finger Tip-
0.32mm | Cuff-
0.11mm
Palm-0.18mm
Finger Tip-
0.21mm | Similar
Meets ASTM D3577-
09(Reapproved 2015), Standard
Specification for Rubber Surgical
Gloves | |
| Tensile Strength
24Mpa minimum | 28.32Mpa | 26.0Mpa | Similar
Meets ASTM D3577-
09(Reapproved 2015), Standard
Specification for Rubber Surgical
Gloves | |
| Ultimate
Elongation
750% minimum | 869% | 860% | Similar
Meets ASTM D3577-
09(Reapproved 2015), Standard
Specification for Rubber Surgical
Gloves | |
| Stress at 500%
5.5 MPa Max | 5.1Mpa | 2.7 Mpa | | |
| Tensile Strength
18Mpa minimum | 23.21Mpa | 22.0Mpa | Similar
Meets ASTM D3577-
09(Reapproved 2015), Standard
Specification for Rubber Surgical
Gloves | |
| Ultimate
Elongation
560% minimum | 730% | 725% | Similar
Meets ASTM D3577-
09(Reapproved 2015), Standard
Specification for Rubber Surgical
Gloves | |
| Characteristics | Acceptance criteria of the standard | | Remarks | |
| | Subject
device
K210969 | Predicate device
K192328 | | |
| Freedom from
Holes
AQL 1.5 | AQL 1.0 | AQL 1.0 | Similar
Meets ASTM D3577 and
ASTM D5151-06,
( Reapproved 2015), Standard Test
Method for Detection of Holes in
Medical Gloves | |
| Powder residue
for powder free
glove Powder
content Pyrogen Test | Non pyrogenic | Non pyrogenic | Same |
| Acute
Systemic
Toxicity | ISO 10993-11:2017(E)
,Biological Evaluation of
Medical Devices - Part
11, Tests for Systemic
Toxicity | Under the
conditions
of study the
device extracts do
not pose a
systemic toxicity
concern | No data available | ---- |
| Bacterial
Endotoxin | USP |