Medical nitrile examination gloves (Model: SH001)

• K Number: K213600
• Device Name: Medical nitrile examination gloves (Model: SH001)
• Manufacturer: Jiangxi SanHao Medical Instruments Co.,Ltd
• Date Cleared: 2022-02-19 ( 96 days)
• Product Code: LZA
• Regulation Number: 880.6250

Intended Use

The Medical nitrile examination gloves (Model: SH001) 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, includes small (S), medium (M), large (L), X-large (XL) for optional. The gloves are provided with blue color, the colorant is Butadiene-Acrylonitrile Copolymers (CAS No.9003-18-3) and Pigment Blue (CAS No.147-14-8). The examination glove is a smooth surface with textured fingertips and a rolled rim at the cuff edge. The Medical nitrile examination gloves meet the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

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 technology.

Therapeutic

No

This device is intended to prevent contamination between patients and examiners, acting as a barrier, rather than providing or supporting a medical treatment or diagnosis for a disease or condition.

Diagnostic

No

The device is a medical glove intended for preventing contamination, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical glove made from nitrile, not software.

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 "intended to be worn on the hands of examiners to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function.
• Device Description: The description focuses on the physical properties and materials of the gloves, consistent with a barrier device.
• Performance Studies: The performance studies evaluate physical properties (dimensions, strength, freedom from holes, residual powder) and biocompatibility (skin irritation, sensitization, systemic toxicity). These are relevant to the safety and effectiveness of a barrier device, not a diagnostic test.
• Key Metrics: The document explicitly states "Not Applicable" for diagnostic performance metrics like sensitivity, specificity, PPV, and NPV. This further confirms it's not a diagnostic device.
• IVD Definition: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform any such tests.

Therefore, based on the provided information, the Medical nitrile examination gloves are a Class I medical device intended for barrier protection, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Medical nitrile examination gloves (Model: SH001) 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, includes small (S), medium (M), large (L), X-large (XL) for optional. The gloves are provided with blue color, the colorant is Butadiene-Acrylonitrile Copolymers (CAS No.9003-18-3) and Pigment Blue (CAS No.147-14-8). The examination glove is a smooth surface with textured fingertips and a rolled rim at the cuff edge. The Medical nitrile examination gloves meet the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

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:

1. 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
   • Acceptance Criteria:
     • Width: For S: 80+/-10 mm; For M: 95+/-10 mm; For L: 110+/-10 mm; For XL: 120+/-10 mm
     • Length: For S: >=220 mm; For M: >=230 mm; For L: >=230 mm; For XL: >=230 mm
     • Thickness: Finger: >=0.05mm; Palm: >=0.05mm
   • Test Results:
     • Lot Batch of 20210723C1: Width: S: 7984mm, M: 9397mm, L: 104-107mm, XL: 112-115mm (all passed); Length: S: 231235mm, M: 234238mm, L: 237240mm, XL: 238243mm (all passed); Thickness: Finger min: 0.13mm for all lots, S/M/L/XL (passed)
     • Lot Batch of 20210719A1: Width: S: 8083mm, M: 9396mm, L: 104107mm, XL: 112116mm (all passed); Length: S: 231235mm, M: 235238mm, L: 237240mm, XL: 239243mm (all passed)
     • Lot Batch of 20210726A0: Width: S: 7983mm, M: 9497mm, L: 104107mm, XL: 112116mm (all passed); Length: S: 232235mm, M: 235238mm, L: 237240mm, XL: 238243mm (all passed)
   • Conclusion: Passed for all batches.

2. ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Properties

   • Test Purpose: To determine the tensile strength and ultimate elongation before and after acceleration aging
   • Acceptance Criteria: Before Aging: Tensile Strength: >= 14Mpa, Ultimate Elongation: >= 500%; After Aging: Tensile Strength: >= 14Mpa, Ultimate Elongation: >= 400%
   • Test Results: For all three lots: Before Aging: Tensile Strength: >= 14Mpa, Ultimate Elongation: >= 500%; After Aging: Tensile Strength: >= 14Mpa, Ultimate Elongation: >= 400% (all passed)
   • Conclusion: Passed for all batches.

3. 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
   • Acceptance Criteria: AQL 2.5
   • Test Results: For all three lots: Pass at AQL 2.5
   • Conclusion: Passed for all batches.

4. 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
   • Acceptance Criteria:

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

0

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February 19, 2022

Jiangxi SanHao Medical Instruments Co.,Ltd % Cassie Lee Manger Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road Huangpu District, Guangzhou, Guangdong China

Re: K213600

Trade/Device Name: Medical nitrile examination gloves (Model: SH001) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: January 21, 2022 Received: January 24, 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.

1

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 (DICE(@fda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely,

Clarence W. Murray III -S

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

2

Indications for Use

510(k) Number (if known) K213600

Device Name

Medical nitrile examination gloves (Model: SH001)

Indications for Use (Describe)

The Medical nitrile examination gloves (Model: SH001) 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 of K213600

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

1. Date of the summary prepared: January 29, 2022

2. Submitter's Information

Sponsor Name: Jiangxi SanHao Medical Instruments Co.,Ltd Address: Chengxi Industrial Park, Jishui County, Ji'an City, Jiangxi Province. China Post Code: 331699 Contact name: Wanqfenfanq (General Manager) Tel: [phone] Phone: [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: SH001 Review Panel: General Hospital Product Code: LZA Requlation Number: 21 CFR 880.6250 Regulatory Class: Class I

4. Predicate Device Information

Sponsor: Guang Dong Kingfa SCI. & TECH.CO., LTD.

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Common Name: Polymer Patient Examination Glove 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, includes small (S), medium (M), large (L), X-large (XL) for optional. The gloves are provided with blue color, the colorant is Butadiene-Acrylonitrile Copolymers (CAS No.9003-18-3) and Pigment Blue (CAS No.147-14-8). The examination glove is a smooth surface with textured fingertips and a rolled rim at the cuff edge. The Medical nitrile examination gloves meet the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

6. Intended Use / Indications for Use

The Medical nitrile examination gloves (Model: SH001) is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powderfree, non-sterile device.

| Elements of

Comparison	Subject Device	Predicate Device	Result
Company	Jiangxi SanHao Medical
Instruments Co.,Ltd	Guang Dong Kingfa SCI. &
TECH.CO., LTD.	--
510 (k) Number	K213600	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 (Model: SH001) is intended
to be worn on	The nitrile examination glove is
intended to be worn on the hands	Similar
Elements of
Comparison	Subject Device	Predicate Device	Result
	the hands of examiners to prevent
contamination between patient and
examiner. This is a single-use,
powder-free, non-sterile device.	of examiners to prevent
contamination between patient
and examiner. This is a single-
use, powder-free, non-sterile
device.
Material of Use	Nitrile rubber	Nitrile rubber	Same
Color	Blue	Blue	Same
Texture	Finger Textured	Finger Textured	Same
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	Meets requirements of the ASTM
D6319-19	Same
	After Aging:
Tensile Strength: ≥14Mpa
Ultimate Elongation: ≥400%	After Aging:
Tensile Strength: Min 14Mpa
Ultimate Elongation: Min 400%	Same
	Thickness
(ASTM D6319-19)	Palm min. 0.05 mm
Finger min. 0.05 mm	Palm min. 0.05 mm
Finger min. 0.05 mm
Elements of
Comparison	Subject Device	Predicate Device	Result
Powder Free
(ASTM D6319-19)	≤2 mg/glove	≤2 mg/glove	Same
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

7. Comparison to predicate device and conclusion

5

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8. Test Summary

8.1 Summary of Non-Clinical Performance Testing

Performance Testing Summary: 1)

| Test Method | Test Purpose | Acceptance
Criteria | Test Results | Conclusion |
|---------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| ASMT D6319-19
Standard
Specification for
Nitrile Examination
Gloves for Medical
Application -
Physical
Dimensions Test | To determine the
width, length,
and thickness of
the gloves | Width:
For S: $80\pm10$ mm
For M: $95\pm10$ mm
For L: $110\pm10$ mm
For XL: $120\pm10$ mm
Length:
For S: $\geq220$ mm
For M: $\geq230$ mm
For L: $\geq230$ mm
For XL: $\geq230$ mm | Lot Batch of
20210723C1:
Width:
For S: 7984mm
For M: 9397mm
For L: 104-107mm
For XL: 112-115mm
Length:
For S: 231235mm
For M: 234238mm | Passed |

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| | For L: 237240mm
For XL: 238243mm | |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Lot Batch of
20210719A1:
Width:
For S: 8083mm
For M: 9396mm
For L: 104107mm
For XL: 112116mm
Length:
For S: 231235mm
For M: 235238mm
For L: 237240mm
For XL: 239243mm | |
| | Lot Batch of
20210726A0:
Width:
For S: 7983mm
For M: 9497mm
For L: 104107mm
For XL: 112116mm
Length:
For S: 232235mm
For M: 235238mm
For L: 237240mm
For XL: 238243mm | |
| Thickness:
Finger: ≥0.05mm
Palm: ≥0.05mm | For all three lots:
For S/M/L/XL:
Finger min: 0.13mm | |

8

| 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:
$\geq$ 14Mpa
Ultimate Elongation:
$\geq$ 500%
After Aging:
Tensile Strength:
$\geq$ 14Mpa
Ultimate Elongation:
$\geq$ 400% | For all three lots:
Before Aging:
Tensile Strength:
$\geq$ 14Mpa
Ultimate Elongation:
$\geq$ 500%
After Aging:
Tensile Strength:
$\geq$ 14Mpa Ultimate
Elongation: $\geq$ 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 |