Medical nitrile examination gloves (Model: JL001)

• K Number: K213848
• Device Name: Medical nitrile examination gloves (Model: JL001)
• Manufacturer: Guangdong Jiali Pharmaceutical Co.,Ltd
• Date Cleared: 2022-03-25 ( 105 days)
• Product Code: LZA
• Regulation Number: 880.6250

Intended Use

The Medical nitrile examination gloves is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

Device Description

The subject device is a powder-free nitrile examination glove, provided as a non-sterile and disposable device. The subject device is mainly made from nitrile and there are four sizes, including small (S), medium (M), large (L), X-large (XL) for optional. The gloves are provided with blue color, the colorant is Pigment Blue (CAS No.147-14-8). The examination glove is a smooth surface and has a rolled rim at the cuff edge.

Predicate Devices

K203593

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and biocompatibility of examination gloves, with no mention of AI or ML technologies.

Therapeutic

No
The device is described as an examination glove intended to prevent contamination, not to treat or cure a disease or condition.

Diagnostic

No

Explanation: The device is an examination glove, intended to prevent contamination between patient and examiner. It does not perform any diagnostic function such as identifying a disease or condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical glove made from nitrile, which is a hardware component. There is no mention of software functionality.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use is "to be worn on the hands of examiners to prevent contamination between patient and examiner." This describes a barrier device used for protection, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
• Device Description: The description details a physical barrier (a glove) made of nitrile. It doesn't mention any reagents, calibrators, controls, or other components typically associated with IVD tests.
• Performance Studies: The performance studies focus on physical properties (tensile strength, freedom from holes) and biocompatibility (skin irritation, sensitization, systemic toxicity). These are relevant for a barrier device, not an IVD. There are no studies related to analytical or clinical performance for diagnosing or monitoring a condition.
• Lack of IVD-Specific Information: The document lacks any mention of typical IVD elements like sample types (blood, urine, etc.), analytes being measured, assay principles, or performance metrics like sensitivity, specificity, or accuracy in a diagnostic context.

In summary, this device is a medical glove intended for barrier protection, not for performing in vitro diagnostic tests.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Medical nitrile examination gloves is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

Product codes

LZA

Device Description

The subject device is a powder-free nitrile examination glove, provided as a non-sterile and disposable device. The subject device is mainly made from nitrile and there are four sizes, including small (S), medium (M), large (L), X-large (XL) for optional. The gloves are provided with blue color, the colorant is Pigment Blue (CAS No.147-14-8). The examination glove is a smooth surface and has a rolled rim at the cuff edge.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hands

Indicated Patient Age Range

Not Found

Intended User / Care Setting

examiners

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

Non-Clinical Performance Testing:

• Test Method: ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Dimensions Test
  • Test Purpose: To determine the width, length, and thickness of the gloves
  • Test Results: Passed for three different lot batches (20210716A, 20210719A, 20210721C) for width, length, and thickness at specified ranges and minimums.
• Test Method: ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Dimensions Test (continuation)
  • Test Purpose: To determine the tensile strength and ultimate elongation before and after acceleration aging
  • Test Results: Passed for all three lots, meeting the specified tensile strength (≥14Mpa) and ultimate elongation (≥500% before aging, ≥400% after aging).
• Test Method: ASTM D6319-19 (ASTM D5151-11) Standard Test Method for Detection of Holes in Medical Gloves
  • Test Purpose: To determine the holes in the gloves
  • Test Results: Passed at AQL 2.5 for all three lots.
• Test Method: ASMT D6319-19 (ASTM D6124-11) Standard Test Method for Residual Powder on Medical Gloves
  • Test Purpose: To determine the residual powder in the gloves
  • Test Results: Passed for all three lots (20210716A, 20210719A, 20210721C) at ≤2.0 mg/glove (results were 0.12 mg/glove, 0.15 mg/glove, 0.21 mg/glove respectively).
    Biocompatibility Testing:
• Test Method: ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin irritation and skin sensitization
  • Test Purpose: To evaluate the potential intracutaneous reactivity caused by intracutaneously injecting the extract to rabbits
  • Test Results: Under the conditions of study not an irritation. Passed.
• Test Method: ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin irritation and skin sensitization
  • Test Purpose: To determine the skin sensitization potential in guinea pigs.
  • Test Results: Under the conditions of the study not a sensitization. Passed.
• Test Method: ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for acute systemic toxicity
  • Test Purpose: The test item was evaluated for acute systemic toxicity in ICR mouse
  • Test Results: Under the condition of acute systemic toxicity test, the test article did not show acute systemic toxicity in vivo. Passed.

No clinical study is included in this submission.

Key Metrics

Width: For S: 7983mm (batch 20210716A), 7983mm (batch 20210719A), 8085mm (batch 20210721C) For M: 9397mm (batch 20210716A), 9497mm (batch 20210719A), 9498mm (batch 20210721C) For L: 101-105mm (batch 20210716A), 101-104mm (batch 20210719A), 105-109mm (batch 20210721C) For XL: 110mm (batch 20210716A), 110mm (batch 20210719A), 110mm (batch 20210721C)
Length: For S: 233237mm (batch 20210716A), 234236mm (batch 20210719A), 230235mm (batch 20210721C) For M: 233237mm (batch 20210716A), 234237mm (batch 20210719A), 235238mm (batch 20210721C) For L: 240244mm (batch 20210716A), 240244mm (batch 20210719A), 239243mm (batch 20210721C) For XL: 240244mm (batch 20210716A), 240245mm (batch 20210719A), 240243mm (batch 20210721C)
Thickness: Finger min: 0.12mm (batch 20210716A), 0.13mm (batch 20210719A), 0.13mm (batch 20210721C) Palm min: 0.08mm (batch 20210716A), 0.08mm (batch 20210719A), 0.08mm (batch 20210721C)
Tensile Strength (Before Aging): ≥14Mpa (for all three lots)
Ultimate Elongation (Before Aging): ≥500% (for all three lots)
Tensile Strength (After Aging): ≥14Mpa (for all three lots)
Ultimate Elongation (After Aging): ≥400% (for all three lots)
Freedom from Holes: Pass at AQL 2.5 (for all three lots)
Residual Powder: 0.12 mg/glove (batch 20210716A), 0.15 mg/glove (batch 20210719A), 0.21 mg/glove (batch 20210721C)

Predicate Device(s)

K203593

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

March 25, 2022

Guangdong Jiali Pharmaceutical Co.,Ltd % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920. Building D3, Miniie Plaza, Shuixi Road, Huang District Guangzhou, Guangdong China

Re: K213848

Trade/Device Name: Medical nitrile examination gloves (Model: JL001) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: February 14, 2022 Received: February 18, 2022

Dear Cassie Lee:

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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213848

Device Name

Medical nitrile examination gloves (Model: JL001)

Indications for Use (Describe)

The Medical nitrile examination gloves is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

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 K213848

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1. Date of the summary prepared: March 15, 2022

2. Submitter's Information

Sponsor Name: Guangdong Jiali Pharmaceutical Co.,Ltd Address: Dawei, Niuqutian Villagers Committee, Muzhou Town, Xinhui, Jiangmen,Guangdong,China Post Code: 529143 Contact name: Jiali Chen Tel: [phone] Tel: [phone] E-mail: [e-mail]

Application Correspondent:

Contact Person: Ms. Cassie Lee Company: Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minije Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: [phone] Email: [e-mail]

3. Subject Device Information

Type of 510(k): Traditional Common Name: Polymer Patient Examination Glove Classification Name: Non-powdered patient examination glove Trade Name: Medical nitrile examination qloves Model Name: JL001 Review Panel: General Hospital Product Code: LZA Requlation Number: 21 CFR 880.6250 Requlatory Class: Class I

4. Predicate Device Information

Sponsor: Guang Dong Kingfa SCI. & TECH.CO., LTD. Common Name: Polymer Patient Examination Glove

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Classification Name: Non-Powdered Patient Examination Glove Trade Name: Patient Examination Gloves 510(k) Number: K203593 Review Panel: General Hospital Product Code: LZA Regulation Number: 21 CFR 880.6250 Regulatory Class: Class I

5. Device Description

The subject device is a powder-free nitrile examination glove, provided as a non-sterile and disposable device. The subject device is mainly made from nitrile and there are four sizes, including small (S), medium (M), large (L), X-large (XL) for optional. The gloves are provided with blue color, the colorant is Pigment Blue (CAS No.147-14-8). The examination glove is a smooth surface and has a rolled rim at the cuff edge.

6. Intended Use / Indications for Use

The Medical nitrile examination gloves is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

7. Comparison to predicate device and conclusion
--------------------------------------------------	--	--

| Elements of

Comparison	Subject Device	Predicate Device	Result
Company	Guangdong Jiali Pharmaceutical
Co.,Ltd	Guang Dong Kingfa SCI. &
TECH.CO., LTD.	--
510 (k) Number	K213848	K203593	--
Trade Name	Medical nitrile examination gloves	Patient Examination Gloves	--
Product Code	LZA	LZA	--
Classification Name	Non-Powdered Patient
Examination Glove	Non-Powdered Patient
Examination Glove	Same
Classification	Class I	Class I	Same
Regulation No.	21 CFR 880.6250	21 CFR 880.6250	Same
Indications For Use	The Medical nitrile examination
gloves is intended to be worn on
the hands of examiners to
prevent contamination between
patient and examiner. This is a	The nitrile examination glove is
intended to be worn on the hands
of examiners to prevent
contamination between patient
and examiner. This is a single-	Same
Elements of
Comparison	Subject Device	Predicate Device	Result
	single-use, powder-free, non-
sterile device.	single-use, powder-free, non-sterile device.
Material of Use	Nitrile rubber	Nitrile rubber	Same
Color	Blue	Blue	Same
Texture	No	Finger Textured	Different
Note
Size
(ASTM D6319-19)	Small, Medium, Large, X Large	Small, Medium, Large, X Large	Same
Sterilization	Non-sterile	Non-sterile	Same
Usage	Single usage	Single usage	Same
Dimensions
(ASTM D6319-19)	Length:
For S: ≥220 mm
For M/L/XL: ≥230 mm	Length:
S (220mm min)
M (230mm min)
L (230mm min)
XL (230mm min)	Same
	Width:
For S: 80±10mm
For M: 95±10 mm
For L: 110±10 mm
For XL: 120±10 mm	Palm width:
Small (80±10mm)
Medium (95±10mm)
Large (110±10mm)
X large (120±10mm)
Physical Properties
(ASTM D6319-19)	Meets requirements of the ASTM
D6319-19
Before Aging:
Tensile Strength: ≥14Mpa
Ultimate Elongation: ≥500%	Meets requirements of the ASTM
D6319-19
Before Aging:
Tensile Strength: Min 14 Mpa
Ultimate Elongation: Min 500%	Same
	Meets requirements of the ASTM
D6319-19
After Aging:
Tensile Strength: ≥14Mpa
Ultimate Elongation: ≥400%	Meets requirements of the ASTM
D6319-19
After Aging:
Tensile Strength: Min 14Mpa
Ultimate Elongation: Min 400%
Thickness
(ASTM D6319-19)	Palm min. 0.05 mm
Finger min. 0.05 mm	Palm min. 0.05 mm
Finger min. 0.05 mm	Same
Powder Free
(ASTM D6319-19)	≤2 mg/glove	≤2 mg/glove	Same
Elements of
Comparison	Subject Device	Predicate Device	Result
Freedom from Holes
(Water Tight -1000 ml)-ASTM D6319-19
(Cross Reference D5151)	Meets requirements of the ASTM
D6319-19	Meets requirements of the ASTM
D6319-19	Same
Biocompatibility -
Skin Sensitization
(ISO 10993-10:2010)	Under the conditions of the study
not a sensitizer	Under the conditions of the study
not a sensitizer	Same
Biocompatibility -
Skin Irritation (ISO
10993-10:2010)	Under the conditions of study not
an irritant	Under the conditions of study not
an irritant	Same
Biocompatibility -
Acute Systemic
Toxicity (ISO 10993-
11: 2017)	Cytotoxicity is assessed via
rationale. Under the condition of
acute systemic toxicity test,
the test article did not show acute
systemic toxicity in vivo.	Cytotoxicity is assessed via
rationale. Under the condition of
acute systemic toxicity test,
the test article did not show acute
systemic toxicity in vivo.	Same

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Comparison in Detail(s):

Note:

Although the subject device has no texture, which is different from the predicate device, both the performance of the subject device and predicate device met the requirements of the standard ASTM D6319-19. So, the difference between the subject device and predicate device will not affect the safety and effectiveness.

8. Test Summary

8.1 Summary of Non-Clinical Performance Testing

1) Performance Testing Summary:

| Test Method | Test Purpose | Acceptance
Criteria | Test Results | Conclusion |
|---------------------|------------------|------------------------|----------------|------------|
| ASMT D6319-19 | To determine the | Width: | Lot Batch of | Passed |
| Standard | width, length, | For S: $80\pm10$ mm | 20210716A: | |
| Specification for | and thickness of | For M: $95\pm10$ mm | Width: | |
| Nitrile Examination | the gloves | For L: $110\pm10$ mm | For S: 7983mm | |
| Gloves for Medical | | For XL: $120\pm10$ mm | For M: 9397mm | |

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| Application -
Physical
Dimensions Test | Length:
For S: ≥220mm
For M: ≥230mm
For L: ≥230mm
For XL: ≥230mm | For L: 101-105mm
For XL: 110mm
Length:
For S: 233237mm
For M: 233237mm
For L: 240244mm
For XL: 240244mm
Lot Batch of
20210719A:
Width:
For S: 7983mm
For M: 9497mm
For L: 101-104mm
For XL: 110mm
Length:
For S: 234236mm
For M: 234237mm
For L: 240244mm
For XL: 240245mm
Lot Batch of
20210721C:
Width:
For S: 8085mm
For M: 9498mm
For L: 105-109mm
For XL: 110mm
Length:
For S: 230235mm
For M: 235238mm
For L: 239243mm
For XL: 240243mm
Lot Batch of
20210716A:
For S/M/L/XL:
Thickness:
Finger: ≥0.05mm
Palm: ≥0.05mm |

----------------------------------------------	------------------------------------------------------------------------------	----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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| | | | Finger min: 0.12mm
Palm min: 0.08mm | |
|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| | | | Lot Batch of
20210719A:
For S/M/L/XL:
Finger min: 0.13mm
Palm min: 0.08mm | |
| | | | Lot Batch of
20210721C:
For S/M/L/XL:
Finger min: 0.13mm
Palm min: 0.08mm | |
| ASMT D6319-19
Standard
Specification for
Nitrile Examination
Gloves for Medical
Application -
Physical
Dimensions Test | To determine the
tensile strength
and ultimate
elongation
before and after
acceleration
aging | Before Aging:
Tensile Strength:
≥14Mpa
Ultimate Elongation:
≥500%
After Aging:
Tensile Strength:
≥14Mpa
Ultimate Elongation:
≥400% | For all three lots:
Before Aging:
Tensile Strength:
≥14Mpa
Ultimate Elongation:
≥500%
After Aging:
Tensile Strength:
≥14Mpa Ultimate
Elongation: ≥400% | Passed |
| ASTM D6319-19
(ASTM D5151-11)
Standard Test
Method for
Detection of Holes
in Medical Gloves | To determine the
holes in the
gloves | AQL 2.5 | For all three lots:
Pass at AQL 2.5 | Passed |
| ASMT D6319-19
(ASTM D6124-11)
Standard Test
Method for
Residual Powder
on Medical Gloves | To determine the
residual powder
in the gloves |