Palm Care Blue Nitrile Examination Gloves Powder Free

K202384 · Hi-Care Thai Gloves Co. , Ltd. · LZA · Dec 2, 2020 · General Hospital

Device Facts

• Record ID: K202384
• Device Name: Palm Care Blue Nitrile Examination Gloves Powder Free
• Applicant: Hi-Care Thai Gloves Co. , Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Dec 2, 2020
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

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

Device Story

Blue Nitrile Examination Gloves are disposable, powder-free patient examination gloves made from acrylonitrile-butadiene copolymer. Designed for use by clinicians and healthcare personnel to provide a protective barrier, preventing cross-contamination between the examiner and the patient. The gloves are worn on the hands during medical examinations or procedures. They are manufactured to meet specific physical property standards, including tensile strength, elongation, and water-tightness, ensuring barrier integrity. The device is a single-use, non-sterile product.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM standards for dimensions, physical properties (tensile strength, elongation), water-tightness (ASTM D5151-06), residual powder (ASTM D6124-06), and biocompatibility (ISO 10993 series).

Technological Characteristics

Material: Acrylonitrile-butadiene copolymer (Nitrile). Form factor: Disposable, powder-free, blue, finger-textured. Standards: ASTM D6319-10 (dimensions, physical properties, thickness), ASTM D5151-06 (water-tightness), ASTM D6124-06 (powder residue), ISO 10993 (biocompatibility).

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 and in general 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

• JR MEDIC Blue Nitrile Examination Gloves Powder free (K192333)

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 2, 2020

Hi-Care Thai Gloves Co. Ltd. % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, Illinois 60504

Re: K202384

Trade/Device Name: Blue Nitrile Examination Gloves Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA Dated: October 31, 2020 Received: November 3, 2020

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

Sincerely,

For: CAPT Elizabeth Claverie, M.S. 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) K202384

Device Name Blue Nitrile Examination Gloves Powder Free

Indications for Use (Describe)

Blue Nitrile Examination Gloves Powder Free is disposable devices intended for medical purpose that are 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)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(K) SUMMARY K202384

Prepared following 21CFR §807.92(C)

Hi-Care Thai Gloves Co. Ltd.

## A. APPLICANT INFORMATION

510(K) Owner's Name Address

| Address | 199Moo.11, T.Banpru, A.Hatyai, Songkhla 90250<br>Thailand. |
|------------------------------|------------------------------------------------------------|
| Phone | [phone] |
| Fax | [phone] |
| E-mail | [e-mail] |
| Contact Person | Mr. Daniel John |
| Designation | International Operations Manager, |
| Contact Number | [phone] |
| Contact Email | [e-mail] |
| Date 510(K) summary prepared | August 14th, 2020 |

#### B. DEVICE IDENTIFICATION

| Name of the device | Blue Nitrile Examination Gloves Powder Free |
|-----------------------------------|-------------------------------------------------------|
| Product proprietary or trade name | Palm Care Blue Nitrile Examination Gloves Powder Free |
| Common or usual name | Patient Examination 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 | JR Engineering & Medical Technologies (M)<br>SDN.BHD. | |
|------------------|-------------------------------------------------------|--|
| 510(k) Number | K192333 | |
| Regulatory Class | 1 | |
| Product code | LZA | |

## D. DESCRIPTION OF THE DEVICE:

Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrilebutadiene copolymer dispersion. These gloves are blue in color and are powder free.

## E. INTENDED USE OF THE DEVICE:

Blue Nitrile Examination Gloves Powder Free 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 PREDICATE DEVICE

| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | | REMARKS |
|-----------------------|----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| | | PREDICATE | SUBJECT | |
| 510(K) Number | | K192333 | K202384 | ---- |
| Name of device | | JR MEDIC Blue Nitrile<br>Examination Gloves<br>Powder free | Blue Nitrile<br>Examination Gloves<br>Powder free | ---- |
| Dimensions | ASTMD 6319-10<br>(Reapproved 2015) | Length Min 230 m<br>Width Min 95+/-10mm<br>(for medium size) | Length Min 230 mm<br>Width Min 95+/mm<br>(for medium size) | Same |
| Physical Properties | ASTMD 6319-10<br>(Reapproved 2015) | <b>Before Aging</b><br>Tensile Strength<br>min 14 Mpa<br>Ultimate Elongation<br>Min 500%<br><b>After Aging</b><br>Tensile Strength<br>min 14 Mpa<br>Ultimate Elongation<br>Min 400% | <b>Before Aging</b><br>Tensile Strength<br>min 14 Mpa<br>Ultimate Elongation<br>Min 500%<br><b>After Aging</b><br>Tensile Strength<br>min 14 Mpa<br>Ultimate Elongation<br>Min 400% | Same |
| Thickness | ASTMD 6319-10<br>(Reapproved 2015) | 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 | ASTMD 6319-10 | $\le$ 2 mg/glove | $\le$ 2 mg/glove | Similar |
| Biocompatibility | 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 |
| | 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) | Under the conditions of<br>the study, cytotoxic | Under the conditions<br>of the study, non-<br>cytotoxic | different |
| | Acute Systemic<br>Toxicity Test ISO<br>10993-11:2017(E) | Under the condition of<br>study not systemic toxic | Under the conditions<br>of study, the device<br>extracts do not pose a<br>systemic toxicity<br>concern | Same |
| | Material Mediated<br>Pyrogenicity ISO<br>10993-11:2017(E) /<br>USP 41<151> | Under the conditions of<br>the study non pyrogenic | Under the conditions<br>of the study non<br>pyrogenic | Same |
| | Bacterial Endotoxin<br>test USP 42<85> | No data available | <20EU/pair of gloves | ---- |
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | | REMARKS |
| | | PREDICATE | CURRENT | |
| Water Tight (1000 ml) | ASTM D 5151-06 | Passes AQL-1.5 | Passes AQL-1.5 | Similar |
| Intended use | | JR MEDIC Blue Nitrile<br>Examination Gloves<br>Powder-free is<br>disposable devices<br>intended for medical<br>purpose that are won on<br>the examiner's hand to<br>prevent contamination<br>between patient and<br>examiner. | Blue Nitrile<br>Examination Gloves<br>Powder free is<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. | Similar |
| Material | ASTMD 6910-10<br>(Reapproved<br>2015) | Nitrile (NBR) | Nitrile (NBR) | Same |
| Color | | Blue | Blue | Same |
| Texture | | Finger Texture | Finger texture | Same |
| Size | ASTMD 6319-10<br>(Reapproved<br>2015) | Extra Small, Small,<br>Medium, Large, Extra<br>Large | Extra Small, Small,<br>Medium, Large, Extra<br>Large | Same |
| Single Use | Medical Glove<br>Guidance Manual<br>- Labeling | Single Use | Single Use | Same |
| Manufacturer(s) | | JR Engineering &<br>Medical<br>Technologies (M)<br>SDN.BHD. Malaysia. | Hi-Care Thai Gloves<br>Co. Ltd. Thailand. | ----- |

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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 D6913-10(Reapproved 2015).

## G. NON-CLINICAL TESTING SUMMARY

## PERFORMANCE DATA

| Test Method | Purpose | Acceptance Criteria | Result |
|------------------------------------------------------------------------------------------------------------------------|------------------------------------------|------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| ASTM D6319-10 (Reapproved<br>2015) Standard Specification for<br>Nitrile Examination Gloves for<br>Medical Application | To determine the length<br>of the gloves | Min 230 mm for all sizes | X-Small:-305 mm<br>Small:-305 mm<br>Medium:-305mm<br>Large:-306mm<br>X-Large:-306mm |
| ASTM D6319-10 (Reapproved<br>2015) Standard Specification for<br>Nitrile Examination Gloves for<br>Medical Application | To determine the width<br>of the gloves | X-small: -70+/-10 mm<br>Small: -80+/-10 mm<br>Medium: -95+/-10mm<br>Large: -110+/-10 mm<br>X-Large: -120+/-10 mm | X-small-74 mm<br>Small: -84 mm<br>Medium: -94 mm<br>Large: -105 mm<br>X-Large: -115 mm |

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| TEST METHOD | PURPOSE | ACCEPTANCE<br>CRITERIA | RESULT | |
|---------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM D6319-10 (Reapproved<br>2015) Standard Specification for<br>Nitrile Examination Gloves for<br>Medical Application | To determine<br>the thickness<br>of the gloves | Palm 0.05 mm min<br>Finger 0.05 mm min for<br>all sizes | Size<br>X-Small<br>Small<br>Medium<br>Large<br>X-Large | Palm    Finger<br>0.10mm    0.13mm<br>0.10mm    0.13mm<br>0.10mm    0.14mm<br>0.10mm    0.13mm<br>0.10mm    0.14mm |
| ASTM D5151-06 (Reapproved<br>2015) Standard Test Method for<br>Detection of Holes in Medical<br>Gloves | To determine<br>the holes in the<br>gloves | AQL 1.5 | Gloves Passes AQL 1.5 | |
| ASTM D6124-06 (Reapproved<br>2017) Standard Test Method for<br>Residual Powder on Medical<br>Gloves | To determine<br>the residual<br>powder in the<br>gloves | 2 Mg/Glove Max | Size<br>X-small<br>Small<br>Medium<br>Large<br>X-Large | Residual Powder Content<br>0.21mg/glove<br>0.21mg/glove<br>0.22 mg/glove<br>0.22 mg/glove<br>0.22 mg/glove |
| ASTM D6319-10<br>(Reapproved 2015) Standard<br>Specification for Nitrile<br>Examination Gloves for Medical<br>Application | To Determine<br>the physical<br>properties-<br>Tensile strength | Before Ageing<br>Tensile Strength 14Mpa<br>Minimal for all sizes<br>After Ageing Tensile<br>Strength 14Mpa<br>Minimal for all sizes | Size<br>X-Small<br>Small<br>Medium<br>Large<br>X-Large | Before    After<br>ageing    ageing<br>18.43Mpa    17.49Mpa<br>18.49Mpa    17.51Mpa<br>18.54Mpa    17.65Mpa<br>18.57Mpa    17.67Mpa<br>18.64Mpa    17.71Mpa |
| | To Determine<br>the physical<br>properties-<br>Ultimate<br>Elongation | Before Ageing<br>Ultimate Elongation<br>500% Min for all sizes<br>After Ageing Ultimate<br>Elongation 400% Min<br>for all sizes | Size<br>X-Small<br>Small<br>Medium<br>Large<br>X-Large | Before    After<br>ageing    ageing<br>685%    654%<br>688%    658%<br>692%    661%<br>695%    665%<br>698%    669% |

## 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 K202384 in 510(K) submission, Blue Nitrile Examination Gloves Powder Free is as effective, and performs as well as or better than the legally marketed predicate device K192333.