Amazing+ Latex Examination Powder Free Gloves

K212597 · Amazing Rubber Products Pvt, Ltd. · LYY · May 28, 2022 · General Hospital

Device Facts

• Record ID: K212597
• Device Name: Amazing+ Latex Examination Powder Free Gloves
• Applicant: Amazing Rubber Products Pvt, Ltd.
• Product Code: LYY · General Hospital
• Decision Date: May 28, 2022
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

Amazing Latex Examination Powder Free Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Amazing+ Latex Examination Powder Free Gloves are disposable natural rubber latex gloves. Worn by clinicians during patient examinations to provide a protective barrier against cross-contamination. The device is non-sterile and powder-free. It functions as a physical barrier; no electronic or mechanical components are involved. The device is used in clinical settings by healthcare providers. It benefits patients and clinicians by reducing the risk of pathogen transmission during routine medical procedures.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM D3578-2019 (dimensions, physical properties), ASTM D5151-2019 (water tightness/holes), ASTM D6124-06 (residual powder), and ASTM D5712-95 (extractable protein). Biocompatibility testing performed per ISO 10993 standards (skin irritation, sensitization, cytotoxicity, pyrogenicity, and acute systemic toxicity).

Technological Characteristics

Material: Natural rubber latex. Form factor: Disposable, non-sterile, powder-free examination glove. Standards: ASTM D3578-2019 (physical properties/dimensions), ASTM D5151-2019 (leakage), ASTM D6124-06 (powder residue), ASTM D5712-95 (protein content). Biocompatibility: ISO 10993-5, 10, 11. No energy source, software, or electronic components.

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 healthcare professionals.

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

• JR MEDIC Blue Latex Examination Powder Free Gloves (K192329)

Submission Summary (Full Text)

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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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

May 28, 2022

Amazing Rubber Products Pvt Ltd % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE114 Aurora, Illinois 60504

Re: K212597

Trade/Device Name: Amazing+ Latex Examination Powder Free Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LYY Dated: May 2, 2022 Received: May 2, 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.

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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Bifeng Qian, M.D., Ph.D. Acting 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) K212597

Device Name

Amazing+ Latex Examination Powder Free Gloves

#### Indications for Use (Describe)

Amazing+ Latex Examination Powder Free Gloves are 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) | |
|-------------------------------------------------|-----------------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | 区 Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510K SUMMARY

# K212597

### As required by 21CFR§807.92(c)

#### A. APPLICANT INFORMATION

| Applicant | Amazing Rubber Products Pvt. Ltd. |
|----------------|----------------------------------------------------------------------------------------|
| Address | Plot No 14c, Cochin Special Economic Zone , Kakkanad,<br>Cochin-682 037, Kerala- India |
| Phone | 9447053062 |
| Fax | -------- |
| E-mail | [e-mail] |
| Contact Person | Mr. Jayasankar S |
| Designation | Executive Director |
| Contact Number | 9447053062 |
| Contact Email | [e-mail] |
| Date Submitted | 12 August 2021 |

#### B. DEVICE IDENTIFICATION

| Name of the device | Amazing+ Latex Examination Powder Free Gloves |
|-----------------------------------|-----------------------------------------------|
| Product proprietary or trade name | Amazing+ |
| Common or usual name | Latex Examination Powder Free Gloves |
| Classification name | Patient Examination Gloves |
| Device Classification | Class I |
| Product Code | LYY |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |

#### C. PREDICATE DEVICE

| | Legally Marketed devices that<br>Equivalency is claimed | JR MEDIC Blue Latex Examination Powder Free Gloves |
|------------------|---------------------------------------------------------|----------------------------------------------------|
| 510(K) Number | K192329 | |
| Regulatory Class | Class I | |
| Product code | LYY | |

#### D. DESCRIPTION OF THE DEVICE:

Amazing Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D3578-2019, Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color (No color is added) and are powder free.

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#### E. INDICATIONS FOR USE/INTENDED USE OF THE DEVICE:

Amazing Latex Examination Powder Free Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.

#### Device Performance Characteristics Comparison Standards Predicate Current K192329 K212597 510(K) Number ---Name of device JR MEDIC Amazing ------Blue Latex Latex Examination Examination Powder Free Gloves Powder Free Gloves Dimensions-ASTM Length > 230 mm Length > 230 mm Length D3578-2019 Similar Size Average X-Small 305 Small 306 Medium 307 Large 308 X-Large 310 Dimensions- Width ASTM Width Min 95+/-Width Min 95+/-10 Similar D3578-2019 10 mm (for mm (for medium size) medium size) Size Average X-Small 76 Small 82 Medium 96 Large 106 X-Large 116 Physical Before Ageing ASTM Before Ageing Similar Properties-D3578-2019 Tensile Strength Tensile Strength > 18 Mpa Tensile > 18 Mpa Size Actual Strength value X-Small 22.07 Small 22.15 Medium 22.22 Large 22.30 X-Large 22.32 After Ageing After Ageing Similar Tensile Tensile Strength > 14 Mpa Strength Size Actual > 14 Mpa value X-Small 18.49 Small 18.56 Medium 18.67 18.74 Large X-Large 18.76

#### F. TECHNOLOGICAL CHARACTERISTICS

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| Characteristics | Standards | Device Performance | | Comparison | | | | | | | | | | | | | | | | | | |
|---------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|--|--|--|--|--|--|--|--|--|--|--|---------|--|--|--|--|--|---------|
| | | Predicate | Current | | | | | | | | | | | | | | | | | | | |
| 510(K) Number | | K192329 | K212597 | | | | | | | | | | | | | | | | | | | |
| Physical Properties-<br>Ultimate Elongation | ASTM<br>D3578-2019 | Before Ageing<br>Ultimate Elongation > 650% | Before Ageing<br>Ultimate Elongation > 650%<br>Size Actual value X-Small 858 Small 869 Medium 874 Large 880 X-Large 882 | | | | | | | | | | | | | Similar | | | | | | |
| | | After Ageing<br>Ultimate Elongation >500% | After Ageing<br>Ultimate Elongation > 500%<br>Size Actual value X-Small 841 Small 848 Medium 854 Large 860 X-Large 862 | | | | | | | | | | | | | | | | | | | |
| Thickness | ASTM<br>D3578-2019 | Palm > 0.08 mm<br>Finger > 0.08 mm | Palm > 0.08 mm<br>Finger > 0.08 mm<br>Size Palm<br>(Actual value) Finger<br>(Actual value) X-Small 0.16 0.22 Small 0.16 0.22 Medium 0.16 0.22 Large 0.16 0.22 X-Large 0.16 0.22 | | | | | | | | | | | | | | | | | | | Similar |
| Powder Free Residue | ASTM D6214 | <2 mg/glove | <2 mg/glove Size Residual<br>powder content<br>(mg/glove) X-Small 0.21 Small 0.21 Medium 0.22 Large 0.22 X-Large 0.22 | | | | | | | | | | | | | Similar | | | | | | |
| Biocompatibility | Primary Skin<br>Irritation-ISO<br>10993-10:2010(E) | Under the condition<br>of study, not an<br>irritant | Under the condition of study<br>not an irritant | Same | | | | | | | | | | | | | | | | | | |
| | Dermal<br>Sensitization-ISO<br>10993-10:2010(E) | Under the conditions<br>of the study, not a<br>sensitizer | Under the conditions of the<br>study, not a sensitizer | Same | | | | | | | | | | | | | | | | | | |
| | In vitro<br>cytotoxicity<br>ISO10993-5<br>:2009(E) | Under the conditions<br>of the study,<br>cytotoxic | Under the conditions of the<br>study, cytotoxic | Same | | | | | | | | | | | | | | | | | | |
| | Material mediated<br>Pyrogenicity<br>ISO 10993-<br>11:2017(E) / USP<br>41<151> | Under the<br>conditions of the<br>study non pyrogenic | Under the conditions of the<br>study, non-pyrogenic | Same | | | | | | | | | | | | | | | | | | |

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| Characteristics | Standards | Device Performance | | Comparison |
|--------------------------|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | | Predicate | Current | |
| 510(K) Number | | K192329 | K212597 | |
| Biocompatibility | Acute Systemic<br>Toxicity Test ISO<br>10993-11:2017(E) | Under the conditions<br>of study the device<br>extracts do not pose a<br>systemic toxicity<br>concern | Under the conditions<br>of study the device extracts<br>do not pose a systemic<br>toxicity concern | same |
| Water Tight<br>(1000 ml) | ASTM D5151-2019 | Passes AQL-1.5 | Passes AQL-1.5 | Same |
| Intended use | | JR MEDIC Blue Latex<br>Examination Powder<br>Free Gloves are<br>disposable devices<br>intended for medical<br>purpose that are won<br>on the examiner's<br>hand to prevent<br>contamination<br>between patient and<br>examiner. | Amazing Latex<br>Examination Powder Free<br>Gloves are disposable<br>devices intended for medical<br>purpose that are worn on the<br>examiner's hand to prevent<br>contamination between<br>patient and examiner. | Same |
| Material | - | Natural Latex | Natural Latex | Identical |
| Color | - | Blue | Natural (No color is added) | different |
| Texture | - | Finger Texture | Finger texture | Identical |
| Size | ASTM D3578-<br>2019 | Small, Medium, Large<br>& X Large | X Small, Small,<br>Medium, Large, X-Large | Similar |
| Single Use | Medical Glove<br>Guidance Manual<br>- Labeling | Single Use | Single Use | Same |
| Sterile/non sterile | - | Non sterile | Non sterile | Same |
| Powder/Powder<br>free | - | Powder free | Powder free | Same |
| Label and Labeling | FDA Label<br>requirements | Meets FDA's label<br>and labeling<br>requirements | Meets FDA's label<br>and labeling<br>requirements | Same |
| Manufacturer(s) | - | JR Engineering &<br>Medical Technologies<br>(M) SDN.BHD.<br>Malaysia | Amazing Rubber Products<br>Pvt. Ltd. | --- |

# G. SUMMARY OF NON-CLINICAL PERFORMANCE DATA

| Test Method | Purpose | Acceptance Criteria | Result |
|----------------------------------------------------------------------------|------------------------------------------|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| ASTM D3578-2019 Standard<br>Specification for Rubber Examination<br>Gloves | To determine the<br>length of the gloves | Min 230 mm for all sizes | X-Small 305 mm<br>Small 306 mm<br>Medium 307 mm<br>Large 308 mm<br>X-Large 310 mm |
| ASTM D3578-2019 Standard<br>Specification for Rubber Examination<br>Gloves | To determine the width<br>of the gloves | X-Small 70+/-10 mm<br>Small 80+/-10mm<br>Medium 95+/-10 mm<br>Large 111+/-10 mm<br>X-Large 115+/-10 mm | X-Small 76 mm<br>Small 85 mm<br>Medium 96 mm<br>Large 106 mm<br>X-Large 116 mm |

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| Test Method | Purpose | Acceptance<br>Criteria | Result | | |
|---------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| ASTM D3578-2019 Standard<br>Specification for Rubber<br>Examination Gloves | To determine the thickness of<br>the gloves | Palm 0.08 mm min<br>Finger 0.08 mm min<br>for all sizes | Size<br>X-Small<br>Small<br>Medium<br>Large<br>X-Large | Palm<br>0.16mm<br>0.16mm<br>0.16mm<br>0.16mm<br>0.16mm | Finger<br>0.22mm<br>0.22mm<br>0.22mm<br>0.22mm<br>0.22mm |
| ASTM D3578-2019<br>Standard Specification for<br>Rubber Examination Gloves | To Determine the physical<br>properties-Tensile strength | Before Ageing<br>Tensile Strength<br>18Mpa Min for all<br>sizes<br>After Ageing<br>Tensile Strength<br>14Mpa Min for all<br>sizes | Size<br>X-Small<br>Small<br>Medium<br>Large<br>X-Large | Before<br>ageing<br>22.07 Mpa<br>22.15 Mpa<br>22.22 Mpa<br>22.30 Mpa<br>22.32 Mpa | After<br>ageing<br>18.49 Mpa<br>18.56 Mpa<br>18.67 Mpa<br>18.74 Mpa<br>18.76 Mpa |
| ASTM D3578-2019<br>Standard Specification for<br>Rubber Examination Gloves | To Determine the physical<br>properties-Ultimate Elongation | Before Ageing<br>Ultimate Elongation<br>650% Min for all<br>sizes<br>After Ageing<br>Ultimate Elongation<br>500% Min for all<br>sizes | Size<br>X-Small<br>Small<br>Medium<br>Large<br>X-Large | Before<br>ageing<br>858%<br>869%<br>874%<br>880%<br>882% | After<br>ageing<br>841%<br>848%<br>854%<br>860%<br>862% |
| | To Determine the physical<br>properties-stress at 500%<br>Elongation | Before Ageing<br>5.5 Mpa Max for all<br>sizes | Size<br>X-Small<br>Small<br>Medium<br>Large<br>X-Large | Before<br>ageing<br>5.1 Mpa<br>5.1 Mpa<br>5.2 Mpa<br>5.2 Mpa<br>5.2 Mpa | NA |
| ASTM D5151-2019 Standard<br>Test Method for Detection of<br>Holes in Medical Gloves | To determine the holes in the<br>gloves | AQL 2.5 | Gloves Passes AQL 1.5 | | |
| ASTM D6124-06<br>(Reapproved 2017) Standard<br>Test Method for Residual<br>Powder on Medical Gloves | To determine the residual<br>powder in the gloves | 2 Mg/Glove Max | Size<br>X-Small<br>Small<br>Medium<br>Large<br>X-Large | Residual Powder<br>Content<br>0.21 mg/glove<br>0.21 mg/glove<br>0.22 mg/glove<br>0.22 mg/glove<br>0.22 mg/glove | |
| ASTM D 5712-95 (Re<br>approved 2010) Standard Test<br>Method for the Analysis of<br>Protein in Natural Rubber | To determine the extractable<br>protein in the gloves. | 200 µg/ dm² Max for<br>all sizes | Size<br>X-Small<br>Small<br>Medium<br>Large<br>X-Large | Extractable<br>Protein content<br>43.65 µg/dm²<br>43.65 µg/dm²<br>43.65 µg/dm²<br>43.65 µg/dm²<br>43.65 µg/dm² | |

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### The performance test data of the non-clinical tests meet following standards:

- A ASTMD 3578-2019 Standard Specification for Rubber Examination Gloves
- ASTMD 5151-2019 Standard Test Method for Detection of Holes in Medical Gloves A
- > ASTMD 6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
- > ASTMD 5712-95 (Re approved 2010) Standard Test Method for the Analysis of Protein in Natural Rubber

#### H. CLINICAL TESTING SUMMARY

This section is not applicable because clinical data not needed for gloves.

## I. CONCLUSION

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission Amazing Latex Examination Powder Free Gloves is as safe, as effective, and performs as well as or better than the legally marketed predicate device JR MEDIC Blue Latex Examination Powder Free Gloves (K192329).