Amazing+
Device Facts
| Record ID | K212586 |
|---|---|
| Device Name | Amazing+ |
| Applicant | Amazing Rubber Products Pvt, Ltd. |
| Product Code | LZA · General Hospital |
| Decision Date | Feb 17, 2022 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
Indications for Use
Sterile Nitrile Patient Examination Gloves Powder Free Blue Color is disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.
Device Story
Disposable sterile nitrile patient examination gloves; worn on examiner's hand; prevents cross-contamination between patient and examiner. Manufactured from acrylonitrile-butadiene copolymer dispersion; blue color; powder-free; finger-textured. Available in sizes X-Small through X-Large. Sterilized via Gamma or ETO. Used in clinical settings by healthcare professionals. Provides physical barrier protection.
Clinical Evidence
Bench testing only. No clinical data. Performance verified against ASTM D6319 (dimensions, physical properties, thickness), ASTM D5151 (water tightness), and ASTM D6124 (powder residue). Biocompatibility testing performed per ISO 10993-5, 10, and 11, and USP <85>/<151> (cytotoxicity, irritation, sensitization, systemic toxicity, pyrogenicity, endotoxin).
Technological Characteristics
Material: Acrylonitrile-butadiene copolymer (nitrile). Standards: ASTM D6319-2019, ASTM D5151-2019, ASTM D6124-06. Form factor: Disposable, finger-textured, blue, powder-free. Sterilization: Gamma or ETO (SAL 10^-6).
Indications for Use
Indicated for use as a disposable medical glove worn on the examiner's hand to prevent contamination between patient and examiner. Suitable for use by clinicians in medical settings.
Regulatory Classification
Identification
A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
Predicate Devices
- Sancare Sterile Nitrile Patient Examination Gloves, Powder free Blue Colour (K171093)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 17, 2022
Amazing Rubber Products Pvt Ltd % Manoj Zacharias Consultant Liberty Management Group Ltd 75 Executive Dr. STE 114 Aurora, Illinois 60504. USA
Re: K212586
Trade/Device Name: Sterile Nitrile Patient Examination Gloves Powder Free Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA 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
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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 mediation-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 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
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# Indications for Use
510(k) Number (if known) K212586
#### Device Name
Sterile Nitrile Patient Examination Gloves Powder Free Blue Color
#### Indications for Use (Describe)
Sterile Nitrile Patient Examination Gloves Powder Free Blue Color is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Type of Use (*Select one or both, as applicable*)
| | Registration Use (Part 21 CFR 601 Subpart D) |
|--|-----------------------------------------------|
| | One-Time Stockpile Use (21 CFR 601 Subpart C) |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510 K SUMMARY K212586 As required by: 21CFR§807.92(c)
#### A. APPLICANT INFORMATION 510(K) Owner's Name Amazing Rubber Products Pvt. Ltd. Address Plot No 14c, Cochin Special Economic Zone , Kakkanad, Cochin-682 037, Kerala- India 9447053062 Phone ----------Fax E-mail info@aaazingglove.com Contact Person Mr. Jayasankar. S Designation Executive Director Contact Number 9447053062 Contact Email info@aaazingglove.com Date Submitted 14 January 2022
# B. DEVICE IDENTIFICATION
| Name of the device | Sterile Nitrile Patient Examination Gloves Powder Free<br>Blue Color |
|-----------------------------------|----------------------------------------------------------------------|
| Product proprietary or trade name | Amazing+ |
| Common or usual name | Exam Gloves |
| Classification name | Patient Examination Gloves |
| Device Classification | Class-1 |
| Product Code | LZA |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |
# C. PREDICATE DEVICE
| Predicate Device | Sancare Sterile Nitrile Patient Examination<br>Gloves, Powder free Blue Colour |
|------------------|--------------------------------------------------------------------------------|
| 510(K) Number | K171093 |
| 510 (K) Owner | Sanrea Healthcare Products Pvt. Ltd. |
| Regulatory Class | 1 |
| Product code | LZA |
# D. DESCRIPTION OF THEDEVICE:
Sterile Nitrile Patient Examination Gloves Powder Free Blue Color are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250).The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free. Both Gamma & ETO sterilized gloves are available in X-Small, Small, Medium, Large & X-Large sizes.
# E. INTENDED USE OF THE DEVICE:
Sterile Nitrile Patient Examination Gloves Powder Free Blue Color is disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.
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# F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATEDEVICE
| Characteristics | Standards | Device Performance | | Remarks |
|-----------------------|----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| | | Predicate | Subject | |
| 510(K) Number | | K171093 | K212586 | --- |
| Name of device | | Sancare Sterile Nitrile<br>Patient Examination<br>Gloves, Powder free<br>Blue Colour | Sterile Nitrile Patient<br>Examination Gloves<br>Powder free Blue<br>Color | Similar |
| Dimensions | ASTM D6319- 2019 | Length Min 230 m<br>Width Min 95+/-10<br>mm(for medium<br>size) | Length Min 230 mm<br>Width Min 95+/-10<br>mm(for medium size) | Same |
| Physical Properties | ASTM D6319- 2019 | Before Aging<br>Tensile Strength<br>min 14 Mpa<br>Ultimate Elongation<br>Min 500%<br>After Aging<br>Tensile Strength<br>min 14 Mpa Ultimate<br>Elongation<br>Min 400% | Before Aging<br>Tensile Strength min<br>14 Mpa<br>Ultimate Elongation<br>Min 500%<br>After Aging<br>Tensile Strength<br>min 14 Mpa<br>Ultimate Elongation<br>Min 400% | Same |
| Thickness | ASTM D6319-2019 | Palm min 0.05 mm<br>Finger min 0.05 mm | Palm min 0.05 mm<br>Finger min 0.05 mm | Same |
| Powder Residue | ASTM D6214 | ≤2 mg/glove | ≤2 mg/glove | Same |
| | Primary Skin<br>Irritation-<br>ISO 10993-<br>10:2010(E) | Under the condition of<br>study not an irritant | Under the condition<br>of study not an<br>irritant | Same |
| Biocompatibility | Dermal<br>Sensitization- ISO<br>10993-10:2010( E) | Under the conditions of<br>the study not a sensitizer | Under the conditions<br>of the study not a<br>sensitizer | Same |
| | In vitro cytotoxicity<br>ISO10993-5<br>:2009(E) | No data available | Under the conditions<br>of the study,<br>cytotoxic | ---- |
| | Acute Systemic<br>Toxicity Test ISO<br>10993-11:2017(E) | No data available | Under the condition<br>of study do not pose<br>a systemic toxicity<br>concern | ---- |
| | Material Mediated<br>Pyrogenicity ISO<br>10993-11:2017(E) /<br>USP 41<151> | No data available | Under the conditions<br>of the study non<br>pyrogenic | ---- |
| | Bacterial Endotoxin<br>test<br>USP 42<85> | No data available | <20EU/pair of gloves | ---- |
| Characteristics | Standards | Device Performance | | Remarks |
| | | Predicate<br>K171093 | Current<br>K212586 | |
| Water Tight (1000 ml) | ASTM D5151-2019 | Passes AQL-1.5 | Passes AQL-1.5 | Similar |
| Intended use | | The Sterile Nitrile<br>Patient Examination<br>gloves Powder free, Blue<br>color, is a disposable<br>device intended for<br>medical purposes that is<br>worn on the examiners'<br>hand or finger to prevent<br>contamination between<br>Patient and examiner. | The Sterile Nitrile<br>Patient Examination<br>gloves Powder free, Blue<br>color, is a disposable<br>device intended for<br>medical purposes that is<br>worn on the examiners'<br>hand or finger to prevent<br>contamination between<br>Patient and examiner. | Similar |
| Material | ASTM D6319-2019 | Nitrile | Nitrile | Same |
| Color | | Blue | Blue | Same |
| Texture | | Finger Texture | Finger texture | Same |
| Size | ASTM D6319-2019 | Extra Small, Small, Medium, Large, Extra<br>Large | Extra Small, Small, Medium, Large, Extra<br>Large | Same |
| Single Use | Medical Glove<br>Guidance Manual<br>- Labeling | Single Use | Single Use | Same |
| Sterile/non sterile | | Sterile- ETO/as well as<br>Radiation,<br>SAL- 10-6 | Sterile -ETO/as well as<br>Radiation,<br>SAL- 10-6 | Same |
| Manufacturer(s) | | Sanrea Healthcare<br>Products Pvt. Ltd. | Amazing Rubber<br>Products Pvt. Ltd | ----- |
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There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods. Both devices meet the ASTM standard D6319.
# G. Non-Clinical Testing Summary
#### PERFORMANCE DATA
| Test Method | Purpose | Acceptance Criteria | Result |
|--------------------------------------------------------------------------------------------------------|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| ASTM D6319-2019 Standard<br>Specification for Nitrile<br>Examination Gloves for<br>Medical Application | To determine the<br>length of the gloves | Min 220 mm for X-small<br>and Small sizes<br>Min 230 mm for other<br>sizes | X-Small:- 303 mm<br>Small:- 304 mm<br>Medium:- 305mm<br>Large:- 306mm<br>X-Large:- 307mm |
| ASTM D6319-2019 Standard<br>Specification for Nitrile<br>Examination Gloves for<br>Medical Application | To determine the<br>width of the gloves | X-small:- $70\pm10$ mm<br>Small:- $80\pm10$ mm<br>Medium:- $95\pm10$ mm<br>Large:- $110\pm10$ mm<br>X-Large:- $120\pm10$ mm | X-small- 74 mm<br>Small:- 84 mm<br>Medium:- 94 mm<br>Large:- 104 mm<br>X-Large:- 115 mm |
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| Test Method | Purpose | Acceptance Criteria | Result | | |
|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|---------------------------------------------------------------------------|--------------------------------------------------------------------------|
| ASTM D6319-2019 Standard Specification for Nitrile Examination Gloves for Medical Application | To determine the thickness of the gloves | Palm 0.05 mm min<br>Finger 0.05 mm min for all sizes | Size<br>X-Small<br>Small<br>Medium<br>Large<br>X-Large | Palm<br>0.10mm<br>0.10mm<br>0.10mm<br>0.10mm<br>0.10mm | Finger<br>0.12mm<br>0.12mm<br>0.12mm<br>0.12mm<br>0.12mm |
| ASTM D6319-2019 Standard Specification for Nitrile Examination Gloves for Medical Application | To Determine the physical properties- Tensile strength | Before Ageing Tensile Strength 14Mpa Min for all sizes<br>After Ageing Tensile Strength 14Mpa Min for all sizes | Size<br>X-Small<br>Small<br>Medium<br>Large<br>X-Large | Before ageing<br>18.44Mpa<br>18.49Mpa<br>18.56Mpa<br>18.62Mpa<br>18.64Mpa | After ageing<br>17.49Mpa<br>17.53Mpa<br>17.65Mpa<br>17.71Mpa<br>17.76Mpa |
| | To Determine the physical properties- Ultimate Elongation | Before Ageing Ultimate Elongation 500% Min for all sizes<br>After Ageing Ultimate Elongation 400% Min for all sizes | Size<br>X-Small<br>Small<br>Medium<br>Large<br>X-Large | Before ageing<br>683%<br>687%<br>692%<br>695%<br>698% | After ageing<br>656%<br>660%<br>663%<br>666%<br>669% |
| Test Method | Purpose | Acceptance Criteria | Result |
|-----------------------------------------------------------------------------------------------------|------------------------------------------------------|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM D5151-2019 Standard<br>Test Method for Detection of<br>Holes in Medical Gloves | To determine the<br>holes in the gloves | AQL 2.5 | Gloves Passes AQL 1.5 |
| ASTM D6124-06 (Reapproved<br>2017) Standard Test Method<br>for Residual Powder on<br>Medical Gloves | To determine the<br>residual powder in<br>the gloves | 2 Mg/Glove Max | Size<br>X-small<br>Small<br>Medium<br>Large<br>X-Large<br>Residual Powder<br>Content<br>0.21mg/glove<br>0.21mg/glove<br>0.22 mg/glove<br>0.22 mg/glove<br>0.22 mg/glove |
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#### BIO-COMPATIBILITY DATA
| Test Method | Purpose | Acceptance Criteria | Result |
|----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-10 Biological<br>Evaluation of Medical Devices<br>Test for Skin Irritation and<br>Skin Sensitization. Test done<br>for irritation. | To determine the potential of<br>the material under test to<br>produce dermal irritation in<br>Rabbits | Under the condition<br>of study not an<br>irritant | Under the condition of<br>study not an irritant |
| ISO 10993-10 Biological<br>Evaluation of Medical Devices<br>Test for Irritation and Skin<br>Sensitization. Test done Skin<br>sensitization. | To determine the skin<br>sensitization potential of the<br>material both in terms of<br>induction and elicitation in<br>Guinea Pig. | Under the<br>conditions of the<br>study not a<br>sensitizer | Under the conditions of<br>the study not a<br>sensitizer |
| ISO 10993-5:2009 biological<br>evaluation of medical devices -<br>part 5, tests for in vitro<br>cytotoxicity. | To evaluate the in vitro<br>cytotoxic potential of the test<br>item (both inner and outer<br>surface) Extracts in L-929<br>mouse fibroblasts cells using<br>elution method. | Under the<br>conditions of study<br>non cytotoxic | Under the conditions of<br>the study cytotoxic. |
| ISO 10993-11:2017 biological<br>evaluation of medical devices -<br>part 11, tests for systemic<br>toxicity. | To determine the acute<br>systemic toxicity potential of<br>the test item extracts (both<br>inside and outer surfaces) in<br>Swiss Albino mice. | Under the<br>conditions of study<br>the device extracts<br>do not pose a<br>systemic toxicity<br>concern | Under the conditions<br>of study the device<br>extracts do not pose a<br>systemic toxicity<br>concern |
| Material Mediated<br>Pyrogenicity ISO 10993-<br>11:2017(E) / USP 41<151> | To determine the pyrogenic<br>potential of the test item<br>extract following intravenous<br>injection in New Zealand<br>white Rabbits. | Under the<br>conditions of the<br>study, the device<br>did not<br>demonstrate a<br>material mediated<br>pyrogenicity<br>response. | Under the conditions of<br>the study, the device did<br>not demonstrate a<br>material mediated<br>pyrogenicity response. |
| Bacterial Endotoxin test<br>USP 42<85> | To determine the bacterial<br>Endotoxin limit in the glove | NMT20 EU/pair of<br>gloves | <20 EU/pair of gloves |
# H. CLINICAL TESTING SUMMARY
Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(K) Process
# I. CONCLUSION
The conclusions drawn from the non clinical test demonstrate that the subject device in 510(K) submission, Sterile Nitrile Patient Examination Gloves Powder Free Blue Color is as safe, as effective, and performs as well as or better than the legally marketed predicate device K171093.
