Nitrile Powder Free Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

Nitrile films form a barrier to body fluids and bloodborne Pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.

AI/ML Overview

The provided document describes the acceptance criteria and performance of the Nitrile Powder Free Patient Examination Gloves, Blue Color based on non-clinical performance data, as clinical data was not deemed necessary for this device.

Here's the breakdown of the information requested:

1. A table of acceptance criteria and the reported device performance

Characteristics	Standard / Acceptance Criteria	Device Performance
Dimension	ASTM standard D 6319-10 (For Length, Width, Thickness)	Meets ASTM standard D 6319-10 (Length: ≥230mm min for all sizes; Width: Small 84-86mm, Medium 94-97mm, Large 105-109mm, X large 114-119mm; Thickness: Finger 0.10mm min, Palm 0.06mm min)
Physical Properties	ASTM standard D 6319-10 (Before aging/after aging: Elongation ≥500%, Tensile Strength ≥ 14MPa)	Meets ASTM standard D 6319-10 (Before aging/after aging: Elongation: 520-580%, Tensile Strength: 22-34 MPa)
Freedom from pinholes	21 CFR 800.20; ASTM D6319-10; ASTM D 5151-06 (Reapproved 2011) (Specifically, for waterleak test on pinhole AQL 2.5 at Inspection Level I)	Meets ASTM D 5151-06 (Reapproved 2011) - Holes at Inspection Level I, AQL 2.5
Powder Residual	ASTM standard D 6319-10 and D6124-06 (Reapproved 2011) (< 2mg/glove)	Meets (< 2mg/glove)
Biocompatibility	Primary Skin Irritation in rabbits (ISO 10993-10: Third Edition 2010-08-01); Dermal sensitization in the guinea pig (ISO 10993-10: Third Edition 2010-08-01)	Passes (Not a Primary Skin Irritation; Not a Dermal sensitization under the conditions of the study)
Materials	Nitrile; PU as Dusting or Donning Powder	Nitrile; PU (Surface Coating Agent)
Intended Use	Non-sterile disposable device for medical purposes, worn on the examiner's hand/finger to prevent contamination between patient and examiner.	Intended Use is Similar to the predicate device: Non-sterile disposable device for medical purposes, worn on the examiner's hand/finger to prevent contamination between patient and examiner. (Note: The provided text refers to it as "disposable device" in the comparison table).
Single Patient Use	Single Patient Use	Single Patient Use (Similar)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes for the specific tests (e.g., how many gloves were tested for pinholes, physical properties, or biocompatibility).
The data provenance is from China, as the submitter, Zhida Glove Co., Ltd., is located in Hebei Province, China. The document does not specify whether the data is retrospective or prospective, but given it's for a 510(k) submission, it would typically be collected as part of product development and testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the reported tests are for physical, chemical, and biological performance of a medical glove, not for diagnostic interpretation requiring human expert consensus. The "ground truth" for these tests is established by adherence to recognized international and national standards (ASTM, ISO, 21 CFR).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for medical imaging studies where disagreements between human readers need to be resolved. The tests performed for this device are objective measurements against established standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This is a medical device (patient examination glove), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This device is a physical product (glove), not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the performance tests conducted on the gloves is based on established industry standards and regulatory requirements. Specifically:
- ASTM standards (D6319-10 for dimensions and physical properties, D5151-06 for freedom from pinholes, D6124-06 for powder residual)
- Federal Regulations (21 CFR 800.20 for freedom from pinholes)
- ISO standards (ISO 10993-10: Third Edition 2010-08-01 for biocompatibility)
8. The sample size for the training set

This information is not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set" for an algorithm. The manufacturing process is subject to quality control, which involves testing samples from production batches.
9. How the ground truth for the training set was established

This information is not applicable for the same reasons as point 8.

Summary

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Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000

December 12, 2014

Zhida Glove Co., Ltd. C/O Mr. Chu Xiaoan Room 1606 Bldg.1. Jianxiang Yuan No. 209 Bei Si Huan Zhong Road, Haidian District. Beijing, 100083 CHINA

Re: K141303

Trade/Device Name: Nitrile Powder Free Patient Examination Gloves, Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: October 28, 2014 Received: October 30, 2014

Dear Mr. Xiaoan,

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141303

Device Name

Nitrile Powder Free Patient Examination Gloves, Blue Color

Indications for Use (Describe)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Section 6 510(k) Summary

510(K) Summary

"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."

= "The assigned 510(k) number is:

Premarket Notification [510(k)] Summary

1.0 Submitter:

Submitter's name :	Zhida Glove Co., Ltd.
Submitter's address :	Tanggang Road, Pachigang Town, LuannanCounty, Hebei Province, 063502, China
Phone number :	(86) 315-4169201
Fax number :	(86) 315-4430333
Name of contact person:	Zhang Liang
Date of preparation :	2014-12-08

2.0 Name of the Device

Device Name:	Nitrile Powder Free Patient ExaminationGloves, Blue Color
Proprietary/Trade name:	Zhida Nitrile Powder Free PatientExamination Gloves, Blue Color
Common Name:	Patient examination glove
Classification Name:	Patient examination glove
Device Classification:	I
Regulation Number:	21 CFR 880.6250
Panel:	General Hospital (80)
Product Code:	LZA

3.0 Predicate device

Device Name:	Nitrile Powder Free Patient Examination Gloves,Cloured (Blue)
Company name:	Tangshan Zhonghong Pulin Plastic Co.,Ltd.
510(K) Number:	K120970

4.0 Device Description:

4.1 How the device functions:

Nitrile films form a barrier to body fluids and bloodborne Pathogens

4.2 Scientific concepts that form the basis for the device

The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a

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medical procedure.

4.3 Physical and performance characteristics such as design, materials and physical properties:

Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.

5.0 Device Intended Use (Indication for use):

6.0 Summary of the Technological Characteristics of the Device:

The Nitrile Powder Free Patient Examination Gloves, Blue Color, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.

Characteristics	Standard	Device performance
Dimension	ASTM standard D 6319-10.	Meets
Physical Properties	ASTM standard D 6319-10.	Meets
Freedom from pinholes	21 CFR 800.20	Meets
Powder Residual	ASTM standard D 6319-10 andD6124-06(Reapproved 2011).	Meets<2mg/glove
Biocompatibility	Primary Skin Irritation in rabbitsISO 10993-10: Third Edition2010-08-01.Dermal sensitization in theguinea pig ISO 10993-10: ThirdEdition 2010-08-01.	PassesNot a Primary SkinIrritationPassesNot a Dermalsensitization

7.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data:

Nitrile Powder Free Patient Examination Gloves, Blue Color, meet requirements per ASTM D6319-10.per ASTM D6124-06(Reapproved 2011), per 21 CFR 800.20 and ISO 10993-10: Third Edition 2010-08-01.

The performance test data of the non clinical tests that support a determination of substantial equivalent is the same as mentioned immediately above.

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8.0 Substantial Equivalent Based on Assessment of Clinical Performance Data:

Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

Features & Description	Predicate Device	Subject Device	Result of Comparison
Company	Tangshan Zhonghong PulinPlastic Co.,Ltd.	Zhida Glove Co., Ltd.	--
510(K) Number	K120970	K141303	--
Product name	Nitrile Powder FreePatient ExaminationGloves, Cloured (Blue)	Nitrile Powder Free PatientExamination Gloves, Blue Color	same
Product Code	LZA	LZA	same
Size	Small/ Medium/Large/X large	Small/ Medium/Large/X large	same
Intend for use	Nitrile Powder Free PatientExaminationGloves,Cloured(Blue) isadisposable device intendedfor medical purposes that isworn on the examiner's handorfinger to preventcontaminationbetweenpatient and examiner.	Nitrile Powder FreePatientExamination Gloves, Blue Color isa disposable device intended formedical purposes that is worn onthe examiner's hand or finger toprevent contaminationbetweenpatient and examiner.	Similar
DeviceDescription andSpecifications	Meets ASTM D6319-10	Meets ASTM D6319-10	Similar
Dimensions--Length	Meets ASTMD6319-10≥230mm min	230mm min for all sizes	Similar
Dimensions-- Width	Meets ASTM D6319-10Small 70-90 mmMedium 85-105mmLarge 100-120mmXlarge 110-130 mm	Small 84-86 mmMedium 94-97mmLarge 105-109mmX large 114-119 mm	Similar
Dimensions--Thickness	Meets ASTM D6319-10Finger 0.05mm min.Palm 0.05mm min.	Thickness (mm) min.Finger 0.10 mm min.Palm 0.06 mm min.	Similar
PhysicalProperties	Meets ASTM D D6319-10Before aging/after agingElongation ≥500%Tensile Strength≥ 14MPa	Before aging/after agingElongation :520-580%Tensile Strength:22-34 MPa	Similar
FreedomfromPinholes	Meets• 21 CFR 800.20• ASTM D6319-10• ASTM D 5151-06(Reapproved 2011)	Meets ASTMD5151-06(Reapproved 2011)Holes atInspection Level IAQL2.5	Similar
Residual Powder	Meets ASTM D 6124-06 (Reapproved 2011)below 2mg of residual powder	Meets ASTM D 6124-06 (Reapproved 2011)Results generated values below 2mg of residual powder	Similar
Materials used to fabricate the devices	Nitrile	Nitrile	Similar
Dusting or Donning Powder:	PU	PU	Similar
Dusting or Donning Powder: name	PU	Surface Coating Agent	Similar
Compare performance data supporting substantial equivalence	Meets ASTM D5151-06 (Reapproved 2011)ASTM D6319-10ASTM D6124-06 (Reapproved 2011)	Meets ASTM D5151-06 (Reapproved 2011)ASTM D6319-10ASTM D6124-06 (Reapproved 2011)	Similar
Single Patient Use	Single Patient Use	Single Patient Use	Similar
Biocompatibility	SKIN IRRITATION DERMAL and SENSITIZATION STUDIES Meets ISO 10993-10:2002/Amd.1:2006	SKIN IRRITATION DERMAL and SENSITIZATION STUDIES Meets ISO 10993-10: Third Edition 2010-08-01.Under the conditions of the study, not an irritant and under conditions of the study, not a sensitizer.	Similar
Labeling for the legally marketed device to which substantial equivalence is claimed.	-Powder Free-Patient Examination Glove-Single Use Only- Manufactured For:- Lot-Blue color- Non sterile	-Powder Free-Patient Examination Glove-Single Use Only- Manufactured For:- Lot-Blue color- Non sterile	Similar

Substantial Equivalence Comparison: 9.0

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10.0 Substantial Equivalence Comparison:

It can be concluded that the Nitrile Powder Free Patient Examination Gloves, Blue Color meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims.

It can be concluded that the Nitrile Powder Free Patient Examination Gloves, Blue Color is as safe, as effective, and performs as well as the predicate device, Nitrile Powder Free Patient Examination Gloves, Cloured (Blue), Tangshan Zhonghong Pulin Plastic Co., Ltd. K120970.

The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device.

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.