PP Care Nitrile Examination Gloves

• K Number: K212629
• Device Name: PP Care Nitrile Examination Gloves
• Manufacturer: EG Group Product and Services CO., Ltd
• Date Cleared: 2022-05-26 ( 280 days)
• Product Code: LZA
• Regulation Number: 880.6250

Intended Use

The PP CARE Nitrile Examination Gloves is a disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

Device Description

PP CARE Nitrile Examination Gloves are Class I patient examination gloves bearing the product code LZA (21CFR880.6250). The gloves are made from acrylonitrile butadiene rubber. These gloves are blue in color and are powder free.

Predicate Devices

K202384

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a pair of examination gloves, and the description focuses on material properties and barrier integrity, with no mention of AI or ML.

Therapeutic

No
The device, examination gloves, is intended to prevent contamination and is not described as treating or alleviating a medical condition.

Diagnostic

No

The device, PP CARE Nitrile Examination Gloves, is described as a disposable device for medical purposes worn on the examiner's hands to prevent contamination. Its performance testing focuses on physical properties and barrier integrity (e.g., length, thickness, tensile strength, holes, biocompatibility), not on detecting or identifying diseases or conditions. It serves as a barrier, not a diagnostic tool.

SaMD (Software as a Medical Device)

No

The device is a physical product (gloves) and the description focuses on material properties and physical performance testing, not software functionality.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states the gloves are for "medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner." This describes a barrier device, not a device used to diagnose a condition or disease.
• Device Description: The description identifies the device as "Class I patient examination gloves." This classification is for general medical devices, not specifically for IVDs.
• Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide information about a patient's health status or disease.
• Performance Studies: The performance studies focus on the physical properties and barrier integrity of the gloves (tensile strength, elongation, leak testing, biocompatibility), which are relevant for a protective barrier device, not a diagnostic device.
• Key Metrics: The document explicitly states "Not Applicable" for key metrics like Sensitivity, Specificity, PPV, and NPV, which are standard metrics for evaluating the performance of diagnostic tests.

In summary, the PP CARE Nitrile Examination Gloves are a medical device intended for protection and contamination prevention, not for in vitro diagnostic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The PP CARE Nitrile Examination Gloves is a disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

Product codes (comma separated list FDA assigned to the subject device)

LZA

Device Description

PP CARE Nitrile Examination Gloves are Class I patient examination gloves bearing the product code LZA (21CFR880.6250). The gloves are made from acrylonitrile butadiene rubber. These gloves are blue in color and are powder free.

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

Not Found

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)

Non-Clinical Testing Summary:

• ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application:
  • Purpose: To determine the length of the gloves. Acceptance Criteria: Min 230 mm for size L. Result: Large: 240 mm.
  • Purpose: To determine the width of the gloves. Acceptance Criteria: Large: 110 +/-10 mm. Result: Large: 105 mm.
  • Purpose: To determine the thickness of the gloves. Acceptance Criteria: Palm 0.05 mm min, Finger 0.05 mm min For all sizes. Result: Size Palm Finger Large 0.10 mm 0.15 mm.
  • Purpose: To Determine the physical properties-Tensile strength. Acceptance Criteria: Before Aging Tensile Strength 14 MPa Minimal for Large size; After Aging Tensile Strength 14 MPa for Large size. Result (Large): Before ageing 17MPa, After ageing 20MPa.
  • Purpose: To Determine the physical properties- Ultimate Elongation. Acceptance Criteria: Before Aging Ultimate Elongation 500% Min for Large size; After Aging Ultimate Elongation 400% Min for Large size. Result (Large): Before ageing 520%, After ageing 512%.
• The Testing of unreferenced nitrile gloves in accordance with EN 455-1 : 2000:
  • Purpose: To determine the holes in the gloves. Acceptance Criteria: Number of samples tested: 200, Number of Leaks allowed: 7. Result: Passed.
• ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application:
  • Purpose: To determine the residual powder in the gloves. Acceptance Criteria: 2 Mg/Glove Max. Result (Large): Residual Powder Content 0.35 mg/glove.
• Biocompatibility (listed under F. Summary of The Technological Characteristics of the device compared to the predicate Device):
  • SKIN IRRITATION TEST OF NITRILE EXAMINATION GLOVE, NON STERILE IN NEW ZEALAND WHITE RABBITS [As per ISO 10993-10:2010(E)]: Result: Under the condition of study not an irritant.
  • SKIN SENSITIZATION STUDY OF NITRILE EXAMINATION GLOVE, NON STERILE IN GUINEA PIGS BY MAXIMIZATION TEST [As per ISO 10993-10:2010(e)]: Result: Under the conditions of the study, not a sensitizer.
  • IN VITRO CYTOTOXICITY STUDY OF NITRILE EXAMINATION GLOVE, NON STERILE BY ELUTION METHOD [As per ISO 10993-5:2009(E)]: Result: Under the conditions of the study, the sample was 100% cytotoxic (Different from predicate).
  • ACUTE SYSTEMIC TOXICITY STUDY OF NITRILE EXAMINATION GLOVE, NON STERILE IN SWISS ALBINO MICE [As per ISO 10993-11:2017]: Result: Under the conditions of the study, the device was non-toxic (Predicate device did not perform this test).

Clinical Testing Summary:
Not applicable- Clinical data is not needed for glove or for most devices by the 510(k) process.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K202384

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

Summary

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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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

May 26, 2022

EG Group Product and Services CO., Ltd % Tim Kania Official Correspondent MDI Consultants Inc. 55 Northen Blvd. Suite 200 Great Neck, New York 11021

Re: K212629

Trade/Device Name: PP Care Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: April 25, 2022 Received: April 26, 2022

Dear Tim Kania:

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.

Clarence W. Murray, III, 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

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Indications for Use

510(k) Number (if known)

K212629

Device Name PP CARE Nitrile Examination Gloves

Indications for Use (Describe)

The PP CARE Nitrile Examination Gloves is a disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

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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Image /page/3/Picture/0 description: The image shows a logo with the letters 'EG' in a stylized font. The 'E' is colored in orange, while the 'G' is in green. The letters are surrounded by a circular design, with the top half of the circle in green and the bottom half in orange. There are two orange dots on either side of the circle, connecting the top and bottom halves.

office : 168/72 Nakniwat Road, Lat Phrao, Lat Phrao, Bangkok 10230 factory : 27/58 M8, Tambon Bueng, Si Racha, Chonburi 20230 Thailand

e-mail: [e-mail] Tel. [phone] Line: @eggroup TEL: [phone]

510(K) SUMMARY K212629

A. APPLICANT INFORMATION

510(K) Owner's Name Address

• Phone Fax E-mail Contact Person Title Contact Number Contact Email Date 510(K) summary prepared
  EG GROUP PRODUCT AND SERVICE CO., LTD 27/58 MOO 8, Tumbon Buen, Sriracha District Sriracha, Chonburu , Thailand 20230 [phone] [phone] [e-mail] Ms.Pakkaporn Phattanaliampaiboon President [phone] [e-mail] February 8th ,2021

DEVICE IDENTIFICATION B.

Name of the device Product proprietary or trade name

Common or usual name Classification name Device Classification Product Code Regulation Number Review Panel

PP CARE Nitrile Examination Gloves PP CARE Nitrile Examination Gloves

Nitrile Examination Gloves POLYMER PATIENT EXAMINATION GLOVE Class-l LZA 21 CFR 880.6250 General Hospital

C. PREDICATE DEVICE

Predicate Device 510(k) Number Regulatory Class l LZA Product code

Hi-Care Thai Gloves Co., Ltd K202384

D. DESCRIPTION OF THE DEVICE:

PP CARE Nitrile Examination Gloves are Class I patient examination gloves bearing the product code LZA (21CFR880.6250). The gloves are made from acrylonitrile butadiene rubber. These gloves are blue in color and are powder free.

E. INTENDED USE OF THE DEVICE:

The PP CARE Nitrile Examination Gloves is a disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

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Image /page/4/Picture/0 description: The image is a logo with the letters 'EG' in a stylized font. The 'E' is orange with a gold outline, and the 'G' is green. The letters are surrounded by a circular design, with the top half being green and the bottom half being orange. There are two small circles on either side of the circular design, one on the top left and one on the bottom right.

EG GROUP PRODUCT AND SERVICE CO., LTD office : 168/72 Nakniwat Road, Lat Phrao, Lat Phrao, Bangkok 10230 factory : 27/58 M8, Tambon Bueng, Si Racha, Chonburi 20230 Thailand.

e-mail: [e-mail] Tel. [phone] Line: @eggroup TEL: [phone]

F. Summary of The Technological Characteristics of the device compared to the predicate Device

CHARACTERISTIC	STANDARDS	DEVICE PERFORMANCE		REMARKS
		PREDICATE	SUBJECT
510(K) Number		K202384	K212629
Name of Device		Blue Nitrile
Examination
Gloves Powder
Free	PP CARE Nitrile
Examination Gloves	----
Dimensions	ASTM D 6319-19	Length Min 230 mm Width Min
110+10/mm (For Large size)	Length Min 240 mm
Width Min 105 mm
(For Large size)	Passed
Physical
Properties	ASTM D 6319-19	Before Aging
Tensile Strength
min 14 Mpa
Ultimate
Elongation
Min 500%
After Aging
Tensile Strength
min 14 Mpa
Ultimate
Elongation Min
400%	Before Aging
Tensile Strength
min 17 Mpa
Ultimate Elongation
Min 520%
After Aging
Tensile Strength
min 20 Mpa
Ultimate Elongation
Min 512%	Passed
Thickness	ASTM D 6319-19	Palm min 0.05 mm
Finger min 0.05
mm	Palm min 0.10 mm
Finger min 0.15 mm	Passed
Powder Residue	ASTM D 6319-19	Before Aging
Tensile Strength
14 MPa Minimal for
Large size
After Aging
Tensile Strength 14
MPa for Large size	Size
Large	Before
ageing
17MPa	After
ageing
20MPa
	To Determine the
physical
properties-
Ultimate
Elongation	Before Aging
Ultimate Elongation
500% Min for Large
size
After Aging
Ultimate Elongation
400% Min for Large
size	Size
Large	Before
ageing
520%	After
ageing
512%

H. Clinical Testing Summary

Not applicable- Clinical data is not needed for glove or for most devices by the 510(k) process.

l. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device, The PP Care Nitrile Examination Gloves, are as safe, as effective, and performs as well as or better than the legally marketed predicate device, Blue Nitrile Examination Gloves Powder Free cleared under K202384.