Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and barrier function of a nitrile examination glove, with no mention of AI or ML technologies.

Therapeutic

No
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, which is a barrier function, not a therapeutic one. It does not treat or cure any medical condition.

Diagnostic

No

The device description clearly states it is a "nitrile patient examination glove," intended for "prevent[ing] contamination between patient and examiner." Its function is protective, not diagnostic.

SaMD (Software as a Medical Device)

No

The device is a physical glove made of nitrile rubber, not software. The description focuses on material properties and physical testing.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the hand or finger. This is a barrier function, not a diagnostic test performed in vitro (outside the body) on specimens like blood, urine, or tissue.
Device Description: The description focuses on the physical properties and material of the glove, not on any reagents, instruments, or procedures used for diagnostic testing.
Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information.
Performance Studies: The performance studies focus on physical properties like tensile strength, elongation, and watertightness, which are relevant to a barrier device, not an IVD.

IVD devices are specifically designed to perform tests on specimens from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This glove does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

A nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

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

LZA

Device Description

Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile is manufactured from nitrile rubber. Innersurface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder or silicone on the glove surface. The glove is ambidextrous, i.e., can be worn on right or left hand.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hand or finger

Indicated Patient Age Range

Not Found

Intended User / Care Setting

examiner

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 Testing was conducted to demonstrate that the proposed device met all required design specifications. The test results demonstrated that the proposed device met the performance criteria as specified utilizing the following test methods, standards, and specifications:

ASTM D6319-10 Standard D6319-10 Standard Specification for Nitrile Examination Gloves o for Medical Application
ASTM D412-2006a (Reapproved 2013) Standard Test Method for Vulcanized Rubber and O Thermoplastic Elastomers-Tension
ASTM D573-2004 (Reapproved 2010) Standard Test Method for Rubber-Deterioration in an o Air Oven
ASTM D3767-03 Standard Practice for Rubber Measurement of Dimensions O
ASTM D5151-2006 (Reapproved 2015) Standard Test Method for Detection of holes in o Medical Gloves
O ASTM D6124-2006 (Reapproved 2015) Standard Tested Method for Residual Powder on Medical Gloves
ISO 2859 Sampling Procedures and Tables for Inspection by Attributes O
ISO 10993-10 Biological Evaluation of medical Devices-Part 10: Tests for Irritation and o Sensitization
ISO 10993-11 Biological Evaluation of Medical Devices-Part 11: Tests for Systemic Toxicity

No clinical studies were conducted for either the subject or predict glove.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Tensile strength: Before aging acceptance criteria Min 14.0 MPa, Results XS - 28.1, S - 28.4, M - 29.2, L - 28.0, XL - 28.9. After aging acceptance criteria Min 14.0 MPa, Results XS - 31.2, S – 30.9, M - 32.3, L - 31.0, XL - 31.3. Status: Pass.
Ultimate elongation: Before aging acceptance criteria Min 500%, Results XS - 540, S - 530, M - 550, L - 540, XL - 540. After aging acceptance criteria Min 400%, Results XS - 460, S – 460, M - 470, L - 490, XL - 480. Status: Pass.
Dimension (Length): X-Small Min 240 mm (result 244 mm), Small Min 240 mm (result 242 mm), Medium Min 240 mm (result 242 mm), Large Min 240 mm (result 243 mm), X-Large Min 240 mm (result 244 mm). All Pass.
Dimension (Width): X-Small 70 ± 10 mm (result 74.0 mm), Small 80 ± 10 mm (result 85.0 mm), Medium 95 ± 10 mm (result 95.0 mm), Large 110 ± 10 mm (result 106 mm), X-Large 120 ± 10 mm (result 115 mm). All Pass.
Dimension (Thickness finger): X-Small min 0.05mm (result 0.10 mm), Small min 0.05mm (result 0.10 mm), Medium min 0.05mm (result 0.10 mm), Large min 0.05mm (result 0.10 mm), X-Large min 0.05mm (result 0.10 mm). All Pass.
Dimension (Thickness palm): X-Small min 0.05mm (result 0.06 mm), Small min 0.05mm (result 0.06 mm), Medium min 0.05mm (result 0.06 mm), Large min 0.05mm (result 0.06 mm), X-Large min 0.05mm (result 0.06 mm). All Pass.
Watertight: Sample size: 315 pcs, Inspection level: G1, AQL: 1.5, Acceptance No. 10. Results: XS - 4 leaks, S - 2 leaks, M - 3 leaks, L - 1 leak, XL - 2 leaks. All within acceptance criteria. Status: Pass.
Residual Powder: Acceptance Criteria Less than 2 mg per glove. Results XS : 0.30mg/glove, S : 0.26mg/glove, M : 0.34mg/glove, L : 0.38mg/glove, XL : 0.40mg/glove. All Pass.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K192333

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 3, 2022

Safeskin Retailing (HK) Limited % Stephan Toupan President Dawa Medical LLC 7320 NW 12th Street Suite 103 Miami, Florida 33126

Re: K222720

Trade/Device Name: Blue Nitrile Powder Free Patient Examination Glove, Non Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA Dated: September 5, 2022 Received: September 8, 2022

Dear Stephan Toupan:

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 (1-800-638-2041 or 301-796-7100).

Sincerely.

Bifeng Qian -S

Bifeng Qian, M.D., Ph.D. 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) K222720

Device Name BLUE NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE, NON STERILE

Indications for Use (Describe)

A nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)	☒

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3

K222720 510(k) SUMMARY

This summary of 510(k) information is submitted in accordance with the requirements of 21 CFR 870.92.

| 1.0 | Submitter:
Name | : | Alvin Ho |
|-----|--------------------------|---|---------------------------------------------------------------------------------------------------------------|
| | Address | : | Safeskin Retailing (HK) Limited
26th Floor, Beautiful Group Tower, 77 Connaught Road
Central, Hong Kong |
| | Phone No. | : | +6012 826 5625 |
| | Date of Summary Prepared | : | 18 Nov 2022 |

2.0 ldentification of the subject device:

Trade Name:	Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile
Common Name:	Patient Examination Gloves
Classification Name:	Patient Examination Gloves
Device Classification:	1
Regulation Number:	21 CFR 880.6250
Product Code:	LZA

3.0 Predicate Device:

K192333

Trade name: Blue Nitrile Examination Gloves Powder Free Company: JR Engineering and Medical Technologies (M) Sdn Bhd

4.0 Description of The Subject Device:

Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile is manufactured from nitrile rubber. Innersurface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder or silicone on the glove surface. The glove is ambidextrous, i.e., can be worn on right or left hand.

5.0 Indication for use:

A Nitrile 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.

6.0 Comparison of the Technological Characteristics with the predicate Device:

The Blue Nitrile Powder-Free Patient Examination Gloves, Non-Sterile are summarized with the following technological characteristics compared to ASTM D6319or equivalent standards as shown in Table

4

Table 1

	STANDARDS	DEVICE PERFORMANCE
CHARACTERISTICS		PREDICATE	CURRENT	COMPARISON
ANALYSIS
		BLUE	BLUE
510(k) Number	-	K192333	K222720
Manufacturer(s)	-	JR Engineering & Medical Technologies
(M) Sdn Bhd.	Safeskin Retailing (HK) Limited
Material	ASTM D6319	Nitrile	Nitrile	Same
Color	-	Blue	Blue	Same
Sterility	-	Non-Sterile	Non-Sterile	Same	Handedness	-	Ambidextrous	Ambidextrous	Same	Product Code	-	LZA	LZA	Same	Physical Properties	ASTM D6319	Before Aging
Tensile Strength:
Ultimate Elongation:		25.6Mpa
868%	28.0 – 32.8 Mpa
530 – 590 %	Different but
within the ASTM
standard	After Aging Tensile
Strength:
Ultimate Elongation:		22.0Mpa
828%	30.9 – 35.1 Mpa
460 - 540%	Different but within the
ASTMstandard	Thickness:

Finger
Palm | ASTM D6319 | 0.22mm0.20mm | Min 0.10mm for (XS, S, M, L, XL)
Min 0.06mm for (XS, S, M, L, XL) | Different but
within the ASTM
standard | - Powder Free | ASTM D6124 | 0.21mg/glove | Below 2mg of residual powder | Different but
within the ASTM
standard |
| Handedness | - | Ambidextrous | Ambidextrous | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Product Code | - | LZA | LZA | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Physical Properties | ASTM D6319 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Before Aging
Tensile Strength:
Ultimate Elongation: | | 25.6Mpa
868% | 28.0 – 32.8 Mpa
530 – 590 % | Different but
within the ASTM
standard | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| After Aging Tensile
Strength:
Ultimate Elongation: | | 22.0Mpa
828% | 30.9 – 35.1 Mpa
460 - 540% | Different but within the
ASTMstandard | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Thickness:
Finger
Palm | ASTM D6319 | 0.22mm0.20mm | Min 0.10mm for (XS, S, M, L, XL)
Min 0.06mm for (XS, S, M, L, XL) | Different but
within the ASTM
standard | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| - Powder Free | ASTM D6124 | 0.21mg/glove | Below 2mg of residual powder | Different but
within the ASTM
standard | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

5

CHARACTERISTICS	STANDARDS	DEVICE PERFORMANCE
		PREDICATE
BLUE	CURRENT
BLUE
Biocompatibility	Primary Skin Irritation

ISO 10993-10:2010
(E) & Consumer
Product Safety
Commission Title 16.
Chapter II, Part 1500 | Under the condition of study not
an irritant | Under conditions of this study, the
test material did not cause an
irritant response. The Primary
Irritant Response Category is
deemed 'Negligible' | Same |
| | Dermal Sensitization-
ISO 10993-10: 2010
(E) & Consumer Product
Safety Commission,
Title 16,Chapter II, Part
1500.3 (c) (4) | Under the condition of the
study not a sensitizer | Under conditions of this study,the
test material did not produce a skin
sensitization effect in the guinea
pigs. | Same |
| | Acute Systemic
Toxicity, ISO 10993-
11:2017 (E) | Under the conditions of study, the
device extracts do not pose a
systemic toxicity concern | Under conditions of this study,the
test item did not induce any
systemic toxicity in Swiss albino
mice. | Same |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON ANALYSIS |
| | | PREDICATE | CURRENT | |
| | | BLUE | BLUE | |
| Watertight (1000ml) | ASTM D5151:2019 | Gloves passes AQL 1.5 | Meets
● 21 CFR 800.20
● ASTM D6319-10
(Reapproved 2015)
Tested in accordance with ASTM
D5151 (Reapproved 2015) with
acceptable results at an AQL 1.5 | Different but within the
ASTM standard. |
| Intended use | – | JR MEDIC BLUE Nitrile Examination
Gloves Powder Free is disposable
devices intended for medical
purpose that are worn on the
examiners hand to prevent
contamination between patient and
examiner | A Nitrile patient examination glove is a
disposable device made of nitrile
rubber intended for medical purposes
that is worn on the examiner's hand or
finger to prevent contamination
between patient and examiner. | Same |
| Size | Medical Glove Guidance
Manual —Labeling | Extra Small
Small
Medium
Large
Extra Large | Extra Small
Small
Medium
Large
Extra Large | Same |
| Single use | Medical Glove Guidance
Manual —Labeling | Single Use | Single Use | Same |

6

7

7.0 Summary of Non-Clinical Testing

| Test

Method	Standard	Purpose of Testing		Acceptance Criteria
Physical
Properties	ASTM D412
(Standard Test Method
for Vulcanized Rubber
and Thermoplastic
Elastomers-Tension)	To evaluate the
tensile (tension)
properties of glove.	Tensile
strength	Before
aging	After
aging	Before
aging	After aging	Pass
				Min 14.0
MPa	Min 14.0
MPa	XS - 28.1
S - 28.4
M - 29.2
L - 28.0
XL - 28.9	XS - 31.2
S – 30.9
M - 32.3
L - 31.0
XL - 31.3
			Ultimate
elongation	Min
500%	Min
400%	XS - 540
S - 530
M - 550
L - 540
XL - 540	XS - 460
S – 460
M - 470
L - 490
XL - 480	Pass

The performance test data of the non-clinical test for this powder free nitrile examination glove is summarized as per below:

8

| Test
Method | Standard | Purpose of
Testing | Glove
Size | Acceptance Criteria | Results | Status | |
|----------------|----------------------------------------------------------------------------------|----------------------------------------------------------|---------------|------------------------------------------|----------------------|--------------------|------|
| Dimension | ASTM D3767
Standard
Practice for
Rubber—
Measurementof
Dimensions | To measure the
length, width and
thickness ofglove | X-Small | Length
Min 240 mm | Length
244 mm | Pass | |
| | | | | Width
$70 \pm 10$ mm | Width
74.0 mm | Pass | |
| | | | | Thickness
Finger – min 0.05mm | Thickness
0.10 mm | Pass | |
| | | | | Palm - min 0.05mm | 0.06 mm | | |
| | | | Small | Length
Min 240 mm | Length
242 mm | Pass | |
| | | | | Width
$80 \pm 10$ mm | Width
85.0 mm | Pass | |
| | | | | Thickness
Finger – min 0.05mm | Thickness
0.10 mm | Pass | |
| | | | | Palm - min 0.05mm | 0.06 mm | | |
| | | | Medium | Length
Min 240 mm | Length
242 mm | Pass | |
| | | | | Width
$95 \pm 10$ mm | Width
95.0 mm | Pass | |
| | | | | Thickness
Finger – min 0.05mm | Thickness
0.10 mm | Pass | |
| | | | | Palm - min 0.05mm | 0.06 mm | | |
| | | | Large | Length
Min 240 mm | Length
243 mm | Pass | |
| | | | | Width
$110 \pm 10$ mm | Width
106 mm | Pass | |
| | | | Thickness | Finger – min 0.05mm
Palm – min 0.05mm | Thickness | 0.10 mm
0.06 mm | Pass |
| | | X-Large | Length | Min 240 mm | Length | 244 mm | Pass |
| | | | Width | $120 \pm 10$ mm | Width | 115 mm | Pass |
| | | | Thickness | Finger – min 0.05mm
Palm – min 0.05mm | Thickness | 0.10 mm
0.06 mm | Pass |

9

10

| Test
Method | Standard | Purpose of
Testing | Acceptance Criteria | Results | Status |
|----------------|---------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Watertight | ASTM D5151
(Standard Test
Method for
Detection of Holesin
Medical Gloves) | To detect holes
that leak water and
thereby
compromise the
usefulness of the
glove. | Sample size: 315 pcs
Inspection level: G1
AQL: 1.5, Acceptance No. 10 | The batch size for this sampling
is 150,001 to500,000. Hence,
according to the singlesampling
plan GI, the sample to be drawn
isunder code M equivalent to
315 pieces with accept 10 and
reject 11 to be accepted under
AQL 1.5.
For Size XS, during the test,
4piece was found with leaks.
Hence it falls within the
acceptance criteria.
For Size S. during the test,
2piece was found with leaks.
Hence it falls within the
acceptance criteria.
For Size M, during the test,
3piece was found with leaks.
Hence it falls within the
acceptance criteria.
For Size L, during the test,
1piece was found
with leaks. Hence it falls
within the acceptance
criteria.
For Size XL, during the
test, 2piece was found
with leaks. Hence it falls
within the acceptance
criteria. | Pass |

11

| Test
Method | Standard | Purpose of
Testing | Acceptance Criteria | Results | Status |
|--------------------|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Residual
Powder | ASTM D6124
(Standard Test Method
for Residual Powder on
Medical Gloves) | To determine the
amount of residual
and non-powder
solids found on
gloves | Less than 2 mg per glove
Requirement :