A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.

Device Description

The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in six sizes: XS, S, M, L, XL, XXL. The subject device is non-sterile.

AI/ML Overview

The provided document is a 510(k) premarket notification for Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs). It details the device's technical characteristics, intended use, and performance testing results to demonstrate substantial equivalence to a predicate device.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The core performance evaluation for these gloves relates to their physical properties, freedom from holes, powder content, biocompatibility, and most importantly, resistance to permeation by chemotherapy drugs.

Test Method	Performance Characteristic	Acceptance Criteria	Reported Device Performance
ASTM D6319	Physical Dimensions Test
	Length (mm) - XS	≥220	> 240/Pass
	Length (mm) - S/M/L/XL/XXL	≥230	> 240/Pass
	Width (mm) - XS	70 ± 10	67-72/Pass
	Width (mm) - S	80 ± 10	76-83/Pass
	Width (mm) - M	95 ± 10	91-99/Pass
	Width (mm) - L	110 ± 10	106-112/Pass
	Width (mm) - XL	120 ± 10	116-124/Pass
	Width (mm) - XXL	130 ± 10	127-134/Pass
	Thickness (mm) - Finger	≥0.05	0.06-0.10/Pass
	Thickness (mm) - Palm	≥0.05	0.07-0.10/Pass
ASTM D5151	Watertightness Test for Detection of Holes	Meet the requirements of ASTM D5151 AQL 2.5	0/125/Pass (This implies 0 holes out of 125 gloves tested, meeting or exceeding AQL 2.5)
ASTM D6124	Powder Content	Meet the requirements of ASTM D6124 ≤ 2.0mg	0.02mg/Pass
ASTM D412	Physical Properties (Tensile Strength & Elongation)
	Before Aging:
	Tensile Strength	≥14MPa	16.4-17.8MPa/Pass
	Ultimate Elongation	≥500%	533-551%/Pass
	After Aging:
	Tensile Strength	≥14MPa	15.8-16.8MPa/Pass
	Ultimate Elongation	≥400%	520-554%/Pass
ISO 10993-5	Biocompatibility - Cytotoxicity	Non- In Vitro Cytotoxicity	Under conditions of the study, device extract is not cytotoxic. /Pass
ISO 10993-10	Biocompatibility - Irritation	Non-irritating	Under the conditions of the study, not an irritant. / Pass
ISO 10993-10	Biocompatibility - Sensitization	Non-sensitizing	Under conditions of the study, not a sensitizer. / Pass
ASTM D6978-05 (Reapproved 2019)	Chemotherapy Drug Permeation (Minimum Breakthrough Detection Time)
	Carboplatin (10.0 mg/ml)	N/A (Comparative to predicate)	> 240 Minutes
	Carmustine (BCNU) (3.3 mg/ml)	N/A (Comparative to predicate)	35.2 Minutes
	Cyclophosphamide (Cytoxan) (20.0 mg/ml)	N/A (Comparative to predicate)	> 240 Minutes
	Doxorubicin (2.0 mg/ml)	N/A (Comparative to predicate)	> 240 Minutes
	Etoposide (20.0 mg/ml)	N/A (Comparative to predicate)	> 240 Minutes
	Fluorouracil (50.0 mg/ml)	N/A (Comparative to predicate)	> 240 Minutes
	Methotrexate (25.0 mg/ml)	N/A (Comparative to predicate)	> 240 Minutes
	Paclitaxel (6.0 mg/ml)	N/A (Comparative to predicate)	> 240 Minutes
	ThioTepa (10.0 mg/ml)	N/A (Comparative to predicate)	76.3 Minutes

Note on Chemotherapy Permeation Acceptance Criteria: The document primarily presents these as reported values and compares them to the predicate device in Table 1 (pages 6-7). The acceptance criteria for these would implicitly be that the breakthrough times are considered sufficient for safe use, or comparable/better than the predicate for equivalent drugs, with a clear warning for drugs with low permeation times. The "Warning: Please do not use with Carmustine (BCNU) and ThioTepa" indicates that the low breakthrough times for these specific drugs are accepted with a cautionary label, rather than requiring an explicit "minimum time" acceptance criterion for regulatory clearance.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the total sample size for all tests performed. However, it does provide a specific sample size for one critical test:

Watertightness Test (ASTM D5151): 125 gloves were tested (indicated by "0/125/Pass").
For other tests (e.g., physical dimensions, tensile strength, powder content, biocompatibility, chemotherapy permeation), the specific number of gloves or samples tested is not explicitly stated in the provided summary, although the ASTM standards themselves would specify statistical sampling plans.
Data Provenance: The tests were conducted by the manufacturer, Yunnan Huazhiyuan Medical Technology Co., Ltd. The location is China. The studies are retrospective in the sense that they are conducted on manufactured devices to demonstrate compliance with standards for the 510(k) submission, rather than being part of a prospective clinical trial.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This section is not applicable to this type of device and submission. The "ground truth" for the performance of these medical gloves is established through adherence to recognized international and national standards (ASTM, ISO) for physical properties, chemical resistance, and biocompatibility, as measured by laboratory equipment and procedures, not by expert human interpretation or consensus. No human "experts" are interpreting images or clinical data for this non-diagnostic device.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly in imaging or diagnostic device evaluations where multiple readers interpret data and discrepancies need to be resolved. For laboratory bench testing against physical and chemical standards, there is no human interpretation needing adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

This section is not applicable. MRMC studies are specific to diagnostic devices, especially those involving image interpretation by multiple human readers, to assess the impact of an AI algorithm on reader performance. This device is a medical glove, a Class I non-diagnostic device, and its performance is evaluated through bench testing against established standards, not human reader studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is not applicable. This device is not an algorithm or AI-based product. Its performance is entirely standalone in the sense that its physical and chemical properties are measured directly from the device itself.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based entirely on laboratory bench testing results measured against predefined acceptance criteria established by recognized international standards (ASTM and ISO).

Physical properties: Measured dimensions, tensile strength, elongation.
Freedom from holes: Tested using a water-tightness test.
Powder content: Measured residual powder.
Biocompatibility: In vitro cytotoxicity, irritation, and sensitization tests.
Chemotherapy drug permeation: Measured breakthrough times using specific chemical assays as per ASTM D6978-05.

8. The Sample Size for the Training Set

This section is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set. The "training" for the device's manufacturing process would be based on quality control and manufacturing specifications, not a data training set.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable as it pertains to AI/ML devices.

Summary

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December 18, 2021

Yunnan Huazhiyuan Medical Technology Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161 Lujiazui East Rd.,Pudong Shanghai. 200120 China

Re: K213051

Trade/Device Name: Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: September 16, 2021 Received: September 22, 2021

Dear Boyle Wang:

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.

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

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

K213051

Device Name

Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)

Indications for Use (Describe)

Chemotherapy Drug	Concentration	Breakthrough Detection Time in Minutes
Carboplatin	10.0 mg/ml(10,000 ppm)	> 240 Minutes
Carmustine (BCNU)	3.3 mg/ml (3,300 ppm)	35.2 Minutes
Cyclophosphamide (Cytoxan)	20.0 mg/ml(20,000 ppm)	> 240 Minutes
Doxorubicin	2.0 mg/ml(2,000 ppm)	> 240 Minutes
Etoposide	20.0 mg/ml(20,000 ppm)	> 240 Minutes
Fluorouracil	50.0 mg/ml(50,000 ppm)	> 240 Minutes
Methotrexate	25.0 mg/ml(25,000 ppm)	> 240 Minutes
Paclitaxel	6.0 mg/ml(6,000 ppm)	> 240 Minutes
ThioTepa	10.0 mg/ml(10,000 ppm)	76.3 Minutes

Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 35.2 Minutes ThioTepa 10.0 mg/ml 76.3 Minutes

Warning: Please do not use with Carmustine (BCNU) and ThioTepa.

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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K213051 510(k) Summary

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

1.0 Submitter's Information

Name: Yunnan Huazhiyuan Medical Technology Co., Ltd. Address: Yangije Industrial Park,Jianshui County,Honghe Hani and Yi Autonomous Prefecture, Yunnan Province,China Contact: Yun Gao Date of Preparation: Sept 16, 2021

Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 Lujiazui East Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn

2.0 Device Information

Nitrile Patient Examination Gloves (Tested for Use with Trade name: Chemotherapy Drugs) Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): XS, S, M, L, XL, XXL

3.0 Classification

Production code: LZA.LZC Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital

4.0 Predicate Device Information

Manufacturer: Ever Growth (Vietnam) Co., Ltd.

Device: Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange Color

510(k) number: K190860

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5.0 Device Description

6.0 Indication for Use

Chemotherapy Drug	Concentration	Breakthrough DetectionTime in Minutes
Carboplatin	10.0 mg/ml(10,000 ppm)	> 240
Carmustine (BCNU)	3.3 mg/ml (3,300 ppm)	35.2
Cyclophosphamide (Cytoxan)	20.0 mg/ml(20,000 ppm)	> 240
Doxorubicin	2.0 mg/ml(2,000 ppm)	> 240
Etoposide	20.0 mg/ml(20,000 ppm)	> 240
Fluorouracil	50.0 mg/ml(50,000 ppm)	> 240
Methotrexate	25.0 mg/ml(25,000 ppm)	> 240
Paclitaxel	6.0 mg/ml(6,000 ppm)	> 240
ThioTepa	10.0 mg/ml(10,000 ppm)	76.3

Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 35.2 Minutes; Thio Tepa 10.0 mg/ml 76.3 Minutes.

Warning: Please do not use with Carmustine (BCNU) and ThioTepa.

7.0 Technological Characteristic Comparison Table

Table1-General Comparison

Item	Subject Device	Predicate Device(K190860)	Remark
Product Code	LZA,LZC	LZA,LZC	Same
Regulation No.	21CFR880.6250	21CFR880.6250	Same
Class	I	I	Same
Intended Use	A patient examinationgloves is a disposabledevice intended for medicalpurpose that is worn on theexaminer's hand orfingers to preventcontamination betweenpatient and examiner. Inaddition, these gloves weretested for use withchemotherapy drugs inaccordance with ASTMD6978-05 StandardPractice for Assessment ofMedical gloves toPermeation byChemotherapy Drugs.	A patient examinationgloves is a disposabledevice intended for medicalpurpose that is worn on theexaminer's hand orfingers to preventcontamination betweenpatient and examiner. Inaddition, these gloves weretested for use withchemotherapy drugs inaccordance with ASTMD6978-05 StandardPractice for Assessment ofMedical gloves toPermeation byChemotherapy Drugs.	Same
Powdered or Poweredfree	Powdered free	Powdered free	Same
Design Feature	Ambidextrous	Ambidextrous	Same
Sterility	Non-Sterile	Non-Sterile	Same
Labeling Information	Single-use indication,powder free, device color,device name, glove size andquantity,Non-Sterile,a statement of standardASTM D6978-05compliance and asummary of the testingresults.	Single-use indication,powder free, device color,device name, glove sizeand quantity, Non-Sterile, astatement of standardASTM D6978-05compliance and asummary of the testingresults.	Same
Dimensions(mm)	Length:XS/S:≥220;M/L/XL/XXL: ≥230;Width:XS: 70±10;S: 80±10;M: 95±10;L: 110±10;XL: 120±10;XXL: 130±10	Length:XS/S/M/L/XL: ≥230;Width:XS:70±10;S: 80±10;M: 95±10;L: 110±10;XL: 120±10	Similar

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	Palm: ≥0.05		Palm: ≥0.05
	Colorant	Blue		White, Orange		Different
PhysicalProperties		TensileStrength	14MPa, min	TensileStrength	14MPa, min	Same
	BeforeAging	UltimateElongation	500% min	UltimateElongation	500% min	Same
	After	TensileStrength	14MPa, min	TensileStrength	14MPa, min	Same
	Aging	UltimateElongation	400%min	UltimateElongation	400%min	Same
	Freedom from Holes		Be free from holes whentested in accordance withASTMD5151 AQL=2.5		Be free from holes whentested in accordancewithASTMD5151AQL=2.5
	Powder Content	0.02 mg per glove, Meetthe requirements ofASTM D6124		Meet the requirements ofASTM D6124		Similar
Biocompatibility		ISO 10993-10;Under the conditions ofthe study, not an irritantor a sensitizer		ISO 10993-10;or a sensitizer	Under the conditions ofthe study, not an irritant	Same
		ISO 10993-5Under conditions of thestudy, device extract isnot cytotoxic		ISO 10993-5not cytotoxic	Under conditions of thestudy, device extract is	Same
		Carboplatin 10.0 mg/ml: >240 Minutes		/		Different
		Carmustine (BCNU)3.3mg/ml: 35.2 Minutes		Carmustine (BCNU) 3.3mg/ml:White:11.8 Minutes;Orange:31.6Minutes		Similar
		l		Cisplatin 1.0 mg/ml: >>240Minutes		Different
		Cyclophosphamide(Cytoxan) 20.0 mg/ml:>240 Minutes		Cyclophosphamide(Cytoxan)20.0 mg/ml: >240 Minutes		Same
		l		Dacarbazine (DTIC) 10.0mg/ml:		Different

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Doxorubicin 2.0 mg/ml: >240 Minutes	Doxorubicin Hydrochloride2.0mg/ml: >240 Minutes	Same
Etoposide 20.0 mg/ml: >240 Minutes	Etoposide (Toposar) 20.0mg/ml: >240 Minutes	Same
Fluorouracil 50.0 mg/ml: >240 Minutes	Fluorouracil 50.0 mg/ml: >240 Minutes	Same
Methotrexate 25.0mg/ml(25,000 ppm): >240Minutes	/	Different
Paclitaxel 6.0 mg/ml: >240Minutes	Paclitaxel (Taxol) 6.0mg/ml:>240 Minutes	Same
ThioTepa 10.0 mg/ml: 76.3Minutes	Thio-Tepa 10.0 mg/ml:White:16.9 Minutes;Orange: 72.5 Minutes	Similar

8.0 Summary of Non-Clinical Testing

Biocompatibility Testing

The biocompatibility evaluation for Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) was conducted in accordance with the following standards:

ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation And Skin Sensitization.

ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity

Performance Testing (Bench)

Physical performance qualities of the proposed device were evaluated per ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.

Permeation testing was conducted to support the addition of the labeling claim: Tested for use with chemotherapy drugs. In addition, the proposed device was tested according to ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by

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Chemotherapy Drugs, in which minimum breakthrough times were determined for a wide range of chemotherapy drugs.

In summary, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:

ASTM D6124-06 (Reapproved 2017), Standard Test Method for -Residual Powder on Medical Gloves
ASTM D5151-19, Standard Test Method for Detection of Holes in । Medical Gloves.
ASTM D6319-19, Standard Specification for Nitrile Examination Gloves । for Medical Application.
-ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

TestMethod	Purpose	Acceptance Criteria	Results
ASTMD6319	PhysicalDimensionsTest	Length(mm):XS: ≥220;S/M/L/XL/XXL: ≥230;Width(mm):XS: 70±10;S: 80±10;M: 95±10;L: 110±10;XL: 120±10;XXL: 130±10	Length(mm):> 240/Pass;Width(mm):XS: 67-72/PassS: 76-83/PassM: 91-99/ PassL: 106-112/ PassXL:116-124/ PassXXL: 127-134/ Pass
		Finger: ≥0.05;Palm: ≥0.05	Thickness (mm):Finger: 0.06-0.10/PassPalm: 0.07-0.10/Pass
ASTMD5151	WatertightnessTestforDetectionofHoles	Meet the requirements of ASTM D5151AQL 2.5	0/125/Pass
ASTMD6124	PowderContent	Meet the requirements of ASTM D6124 <2.0mg	0.02mg/Pass;

Table 2 - Summary of non-clinical performance testing

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ASTMD412	Physicalproperties		TensileStrength	≥14MPa	16.4-17.8MPa/Pass;
		BeforeAging	UltimateElongation	≥500%	533-551%/Pass;
		AfterAging	TensileStrength	≥14MPa	15.8-16.8MPa/Pass;
			UltimateElongation	≥400%	520-554%/Pass;
ISO10993-5	Cytotoxicity	Non- In Vitro Cytotoxicity			Under conditions ofthe study, deviceextract is notcytotoxic. /Pass
ISO10993-10	Irritation	Non-irritating			Under the conditionsof the study, not anirritant. / Pass
ISO10993-10	Sensitization	Non-sensitizing			Under conditions ofthe study, not asensitizer. / Pass

9.0 _Summary of Clinical Testing

Clinical testing is not needed for this device.

10.0 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device, Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) is as safe, as effective, and performs as well as or better than the legally marketed predicated device under K190860.

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.