(197 days)
Not Found
No
The device description and performance studies focus on the physical properties and sterility of surgical gloves, with no mention of AI or ML.
No.
The device is described as a protective barrier (surgical glove) to prevent contamination, not to treat or cure a disease or condition.
No
Explanation: The device is a surgical glove intended to protect a surgical wound from contamination, not to diagnose any condition.
No
The device description explicitly states the device is made of natural rubber latex and is a physical glove, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be worn by operating room personnel to protect a surgical wound from contamination. This is a physical barrier function, not a diagnostic test performed on a sample from the human body.
- Device Description: The description focuses on the physical properties of the glove (material, sterility, size, protein content) and its function as a barrier. There is no mention of analyzing samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or treatment decisions
- Using reagents or assays
This device is clearly a Class II medical device (based on the predicate device classification) intended for surgical use as a protective barrier.
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
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 D3577-2019, 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 is added).
The proposed device is sterilized using Gamma and ETO method to achieve the Sterility Assurance Level (SAL) of 10-6 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
Bench tests were conducted to verify that the proposed device met all design specifications was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards and table below:
ASTM D3577-2019:- Standard Specification for Rubber Surgical Gloves.
ASTM D5151-2019:- 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 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 42 Bacterial Endotoxin Test
Key Metrics
Freedom from Holes AQL 1.5, Powder residue 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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 1, 2022
Amazing Rubber Products Pvt Ltd % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, Illinois 60504
Re: K212596
Trade/Device Name: 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: January 19, 2022 Received: January 19, 2022
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,
Clarence W. Murray, III, Ph.D. 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) K212596
Device Name
Sterile Latex Surgical Gloves Powder Free
Indications for Use (Describe)
A Sterile Latex Surgical Cloves 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) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510K SUMMARY K212596 As required by: 21CFR § 807.92
A. APPLICANT INFORMATION
| 1. | Submitter Name | Amazing Rubber Products Pvt. Ltd. |
|---|---|---|
| 2 | Date Submitted | 14 January 2021 |
| 3 | Address | Plot No 14c, Cochin Special Economic Zone , |
| Kakkanad, Cochin-682 037, | ||
| Kerala- India | ||
| 4 | Phone | 9447053062 |
| 5 | Fax | ----- |
| 6 | info@amazingglove.com | |
| 7 | Contact Person | Jayasankar S |
| 8 | Designation | Executive Director |
| 9 | Contact Number | 9447053062 |
| 10 | Contact Email | info@amazingglove.com |
B. US AGENT & CONTACT PERSON INFORMATION
| 11 | US agent &
contact person name | Manoj Zacharias |
|----|-----------------------------------|----------------------------------------------------------------------------------|
| 12 | Address | Liberty Management Group Ltd.
75 Executive Dr. STE 114 Aurora, IL-60504, USA. |
| 13 | Phone | (630) 270-2921 |
| 14 | Fax | (815) 986-2632 |
| 15 | E-mail | manoj@libertymanagement.us |
C. DEVICE IDENTIFICATION
| 16 | Common Name | Surgical Gloves |
|---|---|---|
| 17 | Device Name | Sterile Latex Surgical Gloves Powder Free |
| Product proprietary or | ||
| trade name | Amazing+ | |
| 18 | Classification name | Surgeon's Gloves |
| 19 | Device Classification | 1 |
| 20 | Product Code | KGO |
| 21 | Regulation Number | 21 CFR 878.4460 |
| 22 | Review Panel | Gen & 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 D3577-2019, 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 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. 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. TECHNOLOGICAL CHARACTERISTICS COMPARISON
a. General Characteristics Comparison
| Characteristic | Subject device
K212596 | Predicate device
K192328 | Comparison | Characteristics | Acceptance criteria of the standard | | Comparison |
|---------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Product Code | KGO | KGO | Same | | Subject device
K212596 | Predicate device
K192328 | |
| Regulation No. | 21 CFR 878.4460 | 21 CFR 878.4460 | Same | Dimensions
Length:- Min
265 mm | 486 mm | 300 mm | Similar
Meets ASTM D3577-2019,
Standard Specification for Rubber
Surgical Gloves |
| Class | 1 | 1 | Same | Size
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) | 80mm
87mm
91mm
97mm
103mm
110mm
116mm | 78mm
85mm
88mm
97mm
103mm
110mm
116mm | Similar
Meets ASTM D3577-2019,
Standard Specification for Rubber
Surgical Gloves |
| Intended 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 | Cuff, Palm,
Finger Tip Min
0.10 mm | Cuff-
0.16mm
Palm-0.21mm
Finger Tip-
0.33mm | Cuff-
0.11mm
Palm-0.18mm
Finger Tip-
0.21mm | Similar
Meets ASTM D3577-2019,
Standard Specification for Rubber
Surgical Gloves |
| Powdered or Powder
free | Powder free | Powder free | Same | Tensile Strength
24Mpa minimum | 28.61Mpa | 26.00Mpa | Similar
Meets ASTM D3577-2019,
Standard Specification for Rubber
Surgical Gloves |
| Material | Natural Rubber | Natural Rubber | Same | Ultimate
Elongation
750% minimum | 871% | 860% | Similar
Meets ASTM D3577-2019,
Standard Specification for Rubber
Surgical Gloves |
| 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 | Stress at 500%
5.5 MPa Max | 5.1Mpa | 2.7 Mpa | |
| Sterilization | ETO/as well as Radiation,
SAL- 10-6 | ETO/as well as Radiation,
SAL- 10-6 | Similar | Tensile Strength
18Mpa minimum | 24.12Mpa | 22.0Mpa | Similar
Meets ASTM D3577-2019,
Standard Specification for Rubber
Surgical Gloves |
| Label and Labeling | Meet FDA's label
Requirements | Meet FDA's label
Requirements | Same | Ultimate
Elongation
| 732% | 725% | |
| 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 | | | | |
6
b. Technological Characteristics Comparison
7
| Characteristics | Acceptance criteria of the standard | Predicate device
K192328 | Subject device
K212596 | Comparison |
|------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Freedom from
Holes
AQL 1.5 | AQL 1.0 | AQL 1.0 | | Similar
Meets ASTM D3577-2019 and
ASTM D5151-2019, 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 |
| 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 42 | 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 42 Bacterial Endotoxin Test
| Test
| Methodology/Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-10 | |||
| Biological Evaluation of | |||
| Medical Devices Test for | |||
| Irritation and Skin | |||
| Sensitization. Test done | |||
| for irritation. | To determine the potential of | ||
| the material under test to | |||
| produce dermal irritation in | |||
| Rabbits | Under the condition | ||
| of study not an | |||
| irritant | Under the | ||
| conditionof | |||
| study not an | |||
| irritant | |||
| ISO 10993-10 | |||
| Biological Evaluation of | |||
| Medical Devices Test for | |||
| Irritation and Skin | |||
| Sensitization. Test done | |||
| Skin sensitization. | To | ||
| determine | |||
| the | |||
| skin | |||
| sensitization potential of the | |||
| material both in terms | |||
| of | |||
| induction | |||
| and elicitation in Guinea | |||
| Pig. | Under the conditions | ||
| of the study not a | |||
| sensitizer | Under the | ||
| conditionsof | |||
| the study not a | |||
| sensitizer | |||
| ISO 10993-5:2009 | |||
| biological evaluation of | |||
| medical devices - part 5, | |||
| tests for in vitro | |||
| cytotoxicity. | To evaluate the in vitro | ||
| cytotoxic potential of the test | |||
| item (both inner andouter | |||
| surface) Extracts in L-929 | |||
| mouse fibroblasts | |||
| cells using elution method. | Under the conditions | ||
| of study non | |||
| cytotoxic | Under the | ||
| conditionsof | |||
| the study | |||
| cytotoxic. | |||
| USP 42 | Bacterial EndotoxinTest |