Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a simple examination glove and the summary contains no mention of AI, ML, or any related technologies.

Therapeutic

No
The device is described as an examination glove intended to prevent contamination between patient and examiner, not to treat or diagnose a medical condition.

Diagnostic

No
Explanation: A diagnostic device is used to identify a disease, condition, or injury. This device, a nitrile examination glove, is intended to prevent contamination between the patient and examiner, which is a protective function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

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

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
Device Intended Use: The intended use of the Purism Non-sterile Powder Free Nitrile Examination Gloves is to be worn on the examiner's hand to prevent contamination between patient and examiner. This is a barrier device used for protection, not a test performed on a sample from the body.
Device Description: The description details the physical characteristics of the gloves (material, color, size, etc.), which are consistent with a protective barrier device, not an IVD.

The information provided clearly indicates that this device is a medical glove used for barrier protection, not an in vitro diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Purism Non-sterile Powder Free Nitrile Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

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

LZA

Device Description

The Purism Non-sterile Powder Free Nitrile Examination Gloves are a non-sterile, powder free, single use, disposable item. The gloves are made from nitrile compound and are blue in color. The gloves are ambidextrous and offered in Small, Medium, Large and X-Large sizes.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hand

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Examiner (medical purposes)

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 performance testing was completed.
Key results from testing against ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application) included:

Length: All sizes (S, M, L, XL) passed the minimum length of 230 mm.
Palm Width: All sizes (S, M, L, XL) passed their respective specified palm width ranges.
Finger Thickness: All sizes (S, M, L, XL) passed their respective specified finger thickness ranges.
Palm Thickness: All sizes (S, M, L, XL) passed their respective specified palm thickness ranges.
Physical Properties (Before Ageing): Tensile Strength min 18.0 MPa (Pass), Ultimate Elongation min 694% (Pass).
Physical Properties (After Ageing): Tensile Strength min 18.2 MPa (Pass), Ultimate Elongation min 664% (Pass).
Results from ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves): Pass at AQL 1.5.
Results from ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves): 0.06 mg/glove (Pass) (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

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Image /page/0/Picture/0 description: The image contains 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 19, 2021

Dezhou Purism Medical Technology Co., Ltd. % Natalya Valerio Consultant mdi Consultants, Inc. 55 Northern Blvd., Suite 201 Great Neck. New York 11021

Re: K211319

Trade/Device Name: Purism Non-Sterile Powder Free 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: July 14, 2021 Received: July 16, 2021

Dear Natalya Valerio:

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For 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) K211319

Device Name

Purism Non-sterile Powder Free Nitrile Examination Gloves

Indications for Use (Describe)

The Purism Non-sterile Powder Free Nitrile Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

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

The assigned 510(k) number is: K211319

Date Summary Prepared: August 3, 2021

1. Submitter's Identification:

Dezhou Purism Medical Technology Co., Ltd. High-end Equipment Manufacturing Park, Minsheng North Road, Economic Development Zone, Pingyuan County, Dezhou City, Shandong Province, 253100 China Tel: +86 15662735157 Contact Person: Mengqi Yang

2. Name of the Device:

Device Trade Name: Purism Non-sterile Powder Free Nitrile Examination Gloves

3. Requlatory Information:

Regulation Name:	Non-Powdered Patient Examination Glove
Regulatory Class:	Class I, reserved
Product Code:	LZA
Regulation Number:	21 CFR 880.6250
Panel:	General Hospital

4. Predicate Device Information:

510(k) #:	K210057
Device:	Blue Nitrile Exam Glove, Powder Free
Manufacturer:	Real Star Medical Technology Co., Ltd.

5. Device Description:

The Purism Non-sterile Powder Free Nitrile Examination Gloves are a non-sterile, powder free, single use, disposable item. The gloves are made from nitrile compound and are blue in color. The gloves are ambidextrous and offered in Small, Medium, Large and X-Large sizes.

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6. Indications for Use:

The Purism Non-sterile Powder Free Nitrile Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Z Technological Comparison to the 510(k) Cleared Predicate Device:

| COMPARISON
CRITERIA | NEW DEVICE
510(K) # K211319 | PREDICATE DEVICE
510(K) # K210057 | COMPARISON
RESULT |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Device Name | Purism Non-sterile Powder
Free Nitrile Examination
Gloves | Blue Nitrile Exam Glove,
Powder Free | N/A |
| Manufacturer | Dezhou Purism Medical
Technology Co., Ltd. | Real Star Medical
Technology Co., Ltd. | N/A |
| Product Code | LZA | LZA | Same |
| Classification | Class 1 | Class 1 | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Indications for
Use | The Purism Non-sterile
Powder Free Nitrile
Examination Gloves is a
disposable device intended
for medical purposes that is
worn on the examiner's
hand to prevent
contamination between
patient and examiner. | The Blue Nitrile Exam
Glove, Powder Free is a
non-sterile disposable
device intended for medical
purposes that is worn on the
examiner's hands or finger
to prevent contamination
between patient and
examiner. | Same |
| Sterile or Non-
Sterile | Non-Sterile | Non-Sterile | Same |
| Reusable or
Disposable
(Single Use) | Disposable (Singe Use) | Disposable (Single Use) | Same |
| Design | Ambidextrous | Ambidextrous | Same |
| Material of
Construction | Nitrile compound | Nitrile compound | Same |
| Size | S, M, L, XL | S, M, L, XL | Same |
| Color | Blue | Blue | Same |

Table 1: Comparison to Predicate Device

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| Powdered or

Powder Free	Powder Free		Powder Free		Same
Glove
Thickness	Size	Finger
(mm)	Palm
(mm)	Size	Finger
(mm)	Palm
(mm)	Similar
Both devices
	S	$0.10\pm0.02$	$0.06\pm0.02$	S	$0.08\pm0.03$	$0.08\pm0.03$	are within
	M	$0.10\pm0.02$	$0.06\pm0.02$	M	$0.08\pm0.03$	$0.08\pm0.03$	ASTM D6319-
19
	L	$0.10\pm0.02$	$0.06\pm0.02$	L	$0.08\pm0.03$	$0.08\pm0.03$	specifications
	XL	$0.10\pm0.02$	$0.06\pm0.02$	XL	$0.08\pm0.03$	$0.08\pm0.03$
Glove
Dimensions	Size	Min
Length
(mm)	Palm
Width
(mm)	Size	Min
Length
(mm)	Width
(mm)	Similar
Both devices
are within
ASTM D6319-
	S	230	$80\pm10$	S	230	$80\pm10$	19
	M	230	$95\pm10$	M	230	$95\pm10$	specifications
	L	230	$110\pm10$	L	230	$110\pm10$
	XL	230	$\ge110$	XL	230	$120\pm10$
Performance Testing
ASTM D6319-
19
Physical
Properties	Before Ageing
Tensile Strength
min 14 MPa
Ultimate Elongation
min 500%
After Ageing			Before Ageing
Tensile Strength
min 14 MPa
Ultimate Elongation
min 500%
After Ageing			Same
	Tensile Strength
min 14 MPa
Ultimate Elongation
min 400%			Tensile Strength
min 14 MPa
Ultimate Elongation
min 400%
ASTM D5151-
19
Freedom from
Holes	Passed at AQL 1.5			Passed at AQL 2.5			Similar
Both devices
are within
ASTM D5151-
19
requirements

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| ASTM D6124-
06
Residual
Powder | ≤2 mg/glove | ≤2 mg/glove | Same
Both devices
are within
ASTM D6124-
requirements | |
|-----------------------------------------|--------------------------------------------------------|-----------------------------------------------------------------------------|-------------------------------------------------------------------|-----------|
| ISO 10993
Biocompatibility | Primary Skin
Irritation
ISO 10993-
10:2010 | Under the
conditions of
study not an
Irritant | Under the conditions of
study not an irritant | Same |
| | Dermal
Sensitization
ISO 10993-
10:2010 | Under the
conditions of
study not a
Sensitizer | Under the conditions of
study not a sensitizer | Same |
| | In vitro
Cytotoxicity
ISO 10993-
5:2009 | Under the
conditions of
Study
Cytotoxic | Under the conditions of
study non-cytotoxic | Different |
| | Acute
Systemic
Toxicity
ISO 10993-
11:2017 | Under the
conditions of
study did not
Show
Systemic
Toxicity | No data available | N/A |

Both the Purism Non-sterile Powder Free Nitrile Examination Gloves and predicate Blue Nitrile Exam Glove, Powder Free are disposable, single use, non-sterile, powder free gloves intended for medical purposes to be worn on the examiner's hand to prevent contamination between patient and examiner.

Both gloves are similar in color, design and sizes. Both gloves are made of nitrile compound.

The only difference was in cytotoxicity test results where the Purism Non-sterile Powder Free Nitrile Examination Gloves showed cytotoxic properties under the conditions of the study. However, additional acute systemic toxicity testing performed under the ISO 10993-11:2017 supported the subject device was not systemically toxic. The results of primary skin irritation and dermal sensitization tests under the ISO 10993-10:2010 standard indicated the subject device was not an irritant or skin sensitizer.

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& Summary of Non-Clinical Tests Performed:

The non-clinical performance testing completed for the Purism Non-sterile Powder Free Nitrile Examination Gloves demonstrated that the subject device met the acceptance criteria or specification for the applicable test methodology or standard as shown below.

Test Method	Purpose	Acceptance Criteria	Results
ASTM D6319-19
Standard
Specification for
Nitrile Examination
Gloves for Medical
Application	To determine glove
length	Min Length
(mm)	Avg Min Length
(mm)
		Size S: 230	Size S: 236 (Pass)
		Size M: 230	Size M: 239 (Pass)
		Size L: 230
Size XL: 230	Size L: 241 (Pass)
Size XL: 238 (Pass)
	To determine glove
palm width	Palm Width
(mm)	Avg Palm Width
(mm)
		Size S: 80±10	Size S: 84 (Pass)
		Size M: 95±10	Size M: 95 (Pass)
		Size L: 110±10
Size XL: ≥110	Size L: 103 (Pass)
Size XL: 111 (Pass)
	To determine glove
finger thickness	Finger Thickness
(mm)	Avg Finger
Thickness
(mm)
		Size S: 0.100±0.02	Size S: 0.096 (Pass)
		Size M: 0.100±0.02	Size M: 0.111 (Pass)
		Size L: 0.100±0.02
Size XL: 0.100±0.02	Size L: 0.108 (Pass)
Size XL: 0.111 (Pass)
	To determine glove
palm thickness	Palm Thickness
(mm)	Avg Palm Thickness
(mm)
		Size S: 0.060±0.02	Size S: 0.058 (Pass)
		Size M: 0.060±0.02	Size M: 0.066 (Pass)
		Size L: 0.060±0.02
Size XL: 0.060±0.02	Size L: 0.074 (Pass)
Size XL: 0.080 (Pass)
ASTM D6319-19
Standard
Specification for
Nitrile Examination
Gloves for Medical
Application	To determine glove
physical properties
before and after
ageing	Before Ageing
Tensile Strength
min 14 MPa
Ultimate Elongation
min 500%	Before Ageing
Tensile Strength
min 18.0 MPa (Pass)
Ultimate Elongation
min 694% (Pass)
		After Ageing	After Ageing
		Tensile Strength
min 14 MPa	Tensile Strength
min 18.2 MPa (Pass)
		Ultimate Elongation
min 400%	Ultimate Elongation
min 664% (Pass)
ASTM D5151-19
Standard Test
Method for Detection
of Holes in Medical
Gloves	To detect holes and
check for water
leaks	As per ISO 2859-1.
GI Level II,
Lot Size 3000,
Sample Size 125,
AQL 1.5, Ac=5, Re=6	Pass at AQL 1.5
ASTM D6124
Standard Test
Method for Residual
Powder on Medical
Gloves	To determine
residual powder	≤2 mg/glove	0.06 mg/glove (Pass)

Table 2: Non-Clinical Tests

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Table 3: Biocompatibility Tests

Test Method	Purpose	Acceptance Criteria	Results
Primary Skin
Irritation
ISO 10993-10:2010	To determine if
device is a skin
irritant	The device must be a
non-irritant	Under the study
conditions not an
irritant
Dermal Sensitization
ISO 10993-10:2010	To determine if
device is a dermal
sensitizer	The device must be a
non-sensitizer	Under the study
conditions not a
sensitizer
In vitro Cytotoxicity
ISO 10993-5:2009	To determine if
device extract is
cytotoxic	The device must be
non-cytotoxic	Under the study
conditions cytotoxic
Acute Systemic
Toxicity
ISO 10993-11:2017	To determine if
device induces
systemic toxicity	The device must not
induce systemic
toxicity	Under the study
conditions did not
induce systemic
toxicity

9. Discussion of Clinical Tests Performed:

Clinical data are not required for marketing clearance of patient examination gloves.

10. Conclusion:

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission K211319, Purism Non-sterile Powder Free Nitrile Examination Gloves, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K210057.