Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical and chemical properties of the glove, with no mention of AI or ML.

Therapeutic

No
The device is described as a "specialty medical glove" intended to "prevent contamination between examiner and patient," which is a barrier function, not a therapeutic one.

Diagnostic

No

Explanation: The device is a medical glove intended to prevent contamination between examiner and patient, not to diagnose a condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical, disposable glove made of nitrile, which is a hardware component.

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 the examiner and patient by being worn on the hand or finger. This is a physical barrier function.
Device Description: The description focuses on the physical characteristics and material of the glove.
Performance Studies: The performance studies evaluate physical properties, barrier function against chemicals, and biocompatibility. These are not diagnostic tests.
Key Metrics: The key metrics are related to physical properties, watertightness, powder content, tensile strength, elongation, biocompatibility, and breakthrough time for chemicals. These are not diagnostic metrics.

IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This glove does not perform any such function. It is a medical device used for protection and barrier purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Tested chemotherapy drugs are as follows:

Chemotherapy Drug	Concentration	Breakthrough Detection Time in Minutes
Carmustine	3.3 mg/ml	22.6 Minutes
Cisplatin	1.0 mg/ml	240 Minutes
Cyclophosphamide	20.0 mg/ml	240 Minutes
Dacarbazine	10.0 mg/ml	240 Minutes
Doxorubicin HCI	2.0 mg/ml	240 Minutes
Etoposide	20.0 mg/ml	240 Minutes
Fluorouracil	50.0 mg/ml	240 Minutes
Methotrexate	25.0 mg/ml	240 Minutes
Mitomycin C	0.5 mg/ml	240 Minutes
Paclitaxel	6.0 mg/ml	240 Minutes
ThioTepa	10.0 mg/ml	11.0 Minutes
Vincristine Sulfate	1.0 mg/ml	240 Minutes

Please note that the following drugs have low permeation times: Carmustine 3.3 mg/ml 22.6 Minutes; ThioTepa 10.0 mg/ml 11.0 Minutes.

Tested Fentanyl Citrate is as follows: Chemotherapy Drug Fentanyl Citrate Injection

Concentration 100.0 mcg/2ml

Breakthrough Detection Time in Minutes 240 Minutes

Product codes

LZA, LZC, ODO, OPJ

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 and Fentanyl Citrate. The gloves are offered in five sizes: XS, S, M, L, XL. The subject device is non-sterile.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hands / hand or finger

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Examiner / Not Found

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)

Biocompatibility Testing:

Conducted in accordance with ISO 10993-10:2010 (Tests for Irritation And Skin Sensitization), ISO 10993-5:2009 (Tests For In Vitro Cytotoxicity), and ISO 10993-11:2017 (Tests for systemic toxicity).
Results: Not an irritant or sensitizer, device extract is cytotoxic, did not show acute systemic toxicity in vivo.

Performance Testing (Bench):

Evaluated per ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application).
Permeation testing conducted according to ASTM D6978-05 (Reapproved 2019) (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs) to determine minimum breakthrough times for chemotherapy drugs.
Other tests performed: 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).

Key Results from Summary of non-clinical performance testing:

Test Method	Purpose	Acceptance Criteria	Results
ASTM D6319	Physical Dimensions Test	Length (mm): XS/S: ≥220; M/L/XL: ≥230. Width (mm): XS: 70±10; S: 80±10; M: 95±10; L: 110±10; XL: 120±10. Finger: ≥0.05; Palm: ≥0.05	Length (mm): XS/S: ≥220; M/L/XL: ≥230. Width (mm): XS: 78-80/Pass S: 83-86/Pass M: 93-96/ Pass L: 103-106/ Pass XL:113-116/ Pass Thickness (mm): Finger: 0.07-0.10/Pass Palm: 0.06-0.07/Pass
ASTM D5151	Watertightness Test for Detection of Holes	Meet the requirements of ASTM D5151 AQL 2.5	0/125/Pass
ASTM D6124	Powder Content	Meet the requirements of ASTM D6124

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 & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.

January 4, 2023

RMKH Glove (Cambodia) Co., Ltd. % Boyle Wang Official Correspondent ABMED Service Inc 1312 17th Street Suite 692 Denver, Colorado 80202

Re: K222907

Trade/Device Name: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, ODO, OPJ Dated: November 15, 2022 Received: November 15, 2022

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

1

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 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., 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) K22907

Device Name

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Indications for Use (Describe)

The Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Tested chemotherapy drugs are as follows:

Chemotherapy Drug	Concentration	Breakthrough Detection Time in Minutes
Carmustine	3.3 mg/ml	22.6 Minutes
Cisplatin	1.0 mg/ml	240 Minutes
Cyclophosphamide	20.0 mg/ml	240 Minutes
Dacarbazine	10.0 mg/ml	240 Minutes
Doxorubicin HCI	2.0 mg/ml	240 Minutes
Etoposide	20.0 mg/ml	240 Minutes
Fluorouracil	50.0 mg/ml	240 Minutes
Methotrexate	25.0 mg/ml	240 Minutes
Mitomycin C	0.5 mg/ml	240 Minutes
Paclitaxel	6.0 mg/ml	240 Minutes
ThioTepa	10.0 mg/ml	11.0 Minutes
Vincristine Sulfate	1.0 mg/ml	240 Minutes

Please note that the following drugs have low permeation times: Carmustine 3.3 mg/ml 22.6 Minutes; ThioTepa 10.0 mg/ml 11.0 Minutes.

Tested Fentanyl Citrate is as follows: Chemotherapy Drug Fentanyl Citrate Injection

Concentration 100.0 mcg/2ml

Breakthrough Detection Time in Minutes 240 Minutes

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

3

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4

510(k) Summary K22907

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

1.0 Submitter's Information

RMKH GLOVE (CAMBODIA) CO., LTD. Name: Address: Manhattan Special Economic Zone, Bavet Commune, Bavet City, Svay Rieng Province, Cambodia Contact: Yang Clement KC Date of Preparation: Dec 28, 2022

Designated Submission Correspondent

Mr. Boyle Wang ABMED SERVICE INC Room 1312 17th Street Suite 692 Denver, CO US 80202 Tel: +86-21-50313932 Email: Info@truthful.com.cn

2.0 Device Information

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

3.0 Classification

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

4.0 Predicate Device Information

Comfort Rubber Gloves Industries Sdn. Bhd Manufacturer: Device: Blue Colored, Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 510(k) number: K192954

5.0 Device Description

5

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 and Fentanyl Citrate. The gloves are offered in five sizes: XS, S, M, L, XL. The subject device is non-sterile.

6.0 Indication for Use

The Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

| Chemotherapy Drug | Concentration | Breakthrough Detection
Time in Minutes |
|----------------------------|---------------|-------------------------------------------|
| Carmustine | 3.3 mg/ml | 22.6 |
| Cisplatin | 1.0 mg/ml | > 240 |
| Cyclophosphamide | 20.0 mg/ml | > 240 |
| Dacarbazine | 10.0 mg/ml | > 240 |
| Doxorubicin HCI | 2.0 mg/ml | > 240 |
| Etoposide | 20.0 mg/ml | > 240 |
| Fluorouracil | 50.0 mg/ml | > 240 |
| Methotrexate | 25.0 mg/ml | > 240 |
| Mitomycin C | 0.5 mg/ml | > 240 |
| Paclitaxel | 6.0 mg/ml | > 240 |
| Thio Tepa | 10.0 mg/ml | 11.0 |
| Vincristine Sulfate | 1.0 mg/ml | > 240 |
| Fentanyl Citrate Injection | 100.0 mcg/2ml | > 240 |

Tested chemotherapy drugs are as follows:

Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 22.6 Minutes; Thio Tepa 10.0 mg/ml 11.0 Minutes.

Warning: Please do not use with Carmustine and ThioTepa.

7.0 Technological Characteristic Comparison Table

6

| Item | Subject Device
(K222907) | Predicate Device
(K192954) | Remark |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Product Code | LZA,LZC,QDO, OPJ | LZA,LZC,QDO | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Nitrile Powder Free
Examination Glove Tested
for Use with
Chemotherapy Drugs and
Fentanyl Citrate is a
specialty medical glove
which is a disposable
device intended for
medical purpose that is
worn on the examiner's
hand or finger to prevent
contamination between
examiner and patient. The
glove was tested for use
with Chemotherapy Drugs
and Fentanyl Citrate as per
ASTM D6978-05 Standard
Practice for Assessment of
Medical Gloves to
Permeation by
Chemotherapy Drugs. | The Blue Colored, Powder
Free Nitrile Examination
Gloves, Non-sterile, and
Tested for Use with
Chemotherapy Drugs and
Fentanyl Citrate is a
specialty medical glove
which is a disposable
device intended for
medical purpose that is
worn on the examiner' s
hand or finger to prevent
contamination between
examiner and patient. The
glove was tested for use
with Chemotherapy Drugs
and Fentanyl Citrate as per
ASTM D6978-05 Standard
Practice for Assessment of
Medical Gloves to
Permeation by
Chemotherapy Drugs. | Same |
| Powdered or Powered free | 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
and quantity,Non-Sterile,
a statement of standard
ASTM D6978-05
compliance and a
summary of the testing
results. | Single-use indication,
powder free, device color,
device name, glove size
and quantity, Non-Sterile,
a statement of standard
ASTM D6978-05
compliance and a
summary of the testing
results. | Same |
| Dimensions(mm) | Length:
XS/S:≥220;
M/L/XL: ≥230; | Length:
XS/S/M/L/XL: ≥240;
Width: | Similar |

Table1-General Comparison

7

	Width:
	XS: 70±10;	XS:70±10;
	S: 80±10;	S: 80±10;
	M: 95±10;	M: 95±10;
	L: 110±10;	L: 110±10;
	XL: 120±10.	XL: 120±10
		Finger: ≥0.05;	Finger: ≥0.05;	Same
	Thickness(mm)		Palm: ≥0.05		Palm: ≥0.05
	Colorant		Blue		Blue	Same
	Physical
Properties	Before
Aging	Tensile
Strength	14MPa,
min	Tensile
Strength	14MPa,
min	Same
			Ultimate
Elongation	500% min	Ultimate
Elongation	500% min	Same
		After Aging	Tensile
Strength	14MPa,
min	Tensile
Strength	14MPa,
min	Same
			Ultimate
Elongation	400%min	Ultimate
Elongation	400%min	Same
	Freedom from Holes		Be free from holes when
tested in accordance
with ASTMD5151
AQL=2.5		Be free from holes when
tested in accordance
with ASTMD5151
AQL=2.5		Same
	Powder Content		0.16~0.30 mg per glove,
Meet the requirements
of ASTM D6124		Meet the requirements
of ASTM D6124		Similar
	Biocompatibility		ISO 10993-10;
Under the conditions of
the study, not an irritant
or a sensitizer
ISO 10993-5
Under conditions of the
study, device extract is
cytotoxic
ISO 10993-11;
Under the
condition of acute
systemic toxicity test,
the test article did not
show acute systemic
toxicity in vivo.		ISO 10993-10;
Under the conditions of
the study, not an irritant
or a sensitizer
ISO 10993-5
Under conditions of the
study, device extract is
cytotoxic
ISO 10993-11;
Under the conditions of
the study, the subject
showed no adverse
biological reaction.		Same
Chemotherapy
Drugs Tested
with Minimum
Breakthrough
Detection Time	Carmustine
3.3 mg/ml	22.6 Minutes		White:18.2 Minutes		Similar
Cisplatin
1.0 mg/ml	>240 Minutes		>240 Minutes		Different
Cyclophosph	>240 Minutes		>240 Minutes		Same

8

| as Tested per
ASTM D 6978 | -amide
20.0 mg/ml | | | |
|------------------------------|------------------------------------------------|--------------|--------------|-----------|
| | Dacarbazine
10.0 mg/ml | >240 Minutes | >240 Minutes | Same |
| | Doxorubicin
HCI
2.0 mg/ml | >240 Minutes | >240 Minutes | Same |
| | Etoposide
20.0 mg/ml | >240 Minutes | >240 Minutes | Same |
| | Fluorouracil
50.0 mg/ml | >240 Minutes | >240 Minutes | Same |
| | Methotrexate
25.0 mg/ml | >240 Minutes | / | Different |
| | Mitomycin C
0.5 mg/ml | >240 Minutes | / | Different |
| | Paclitaxel
6.0 mg/ml | >240 Minutes | >240 Minutes | Same |
| | ThioTepa
10.0 mg/ml | 11.0 Minutes | 57.3 Minutes | Different |
| | Vincristine
Sulfate
1.0 mg/ml | >240 Minutes | / | Different |
| | Fentanyl
Citrate
Injection
100mcg/2ml | >240 Minutes | >240 Minutes | Same |

Analysis 1:

The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D6319-19, so the differences do not raise any new safety or performance questions.

Analysis 2:

Powder Content of subject device is similar with that of the predicate, because the predicate did not publish the exact results of the powder content. But they all meet the requirements of ASTM D6319-19, so the differences do not raise any new safety or performance questions.

Analysis 3:

And Breakthrough detection times of Carmustine and Thio Tepa of subject device are different with those of the predicate. The Chemotherapy Labeling Claims has clearly defined on the labeling. So it does not raise any new safety or performance questions.

9

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

ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity.

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 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.

10

| Test

Method	Purpose	Acceptance Criteria	Results
ASTM
D6319	Physical
Dimensions
Test	Length(mm):
XS/S: ≥220;
M/L/XL: ≥230.	Length(mm):
XS/S: ≥220;
M/L/XL: ≥230.
		Width(mm):
XS: 70±10;
S: 80±10;
M: 95±10;
L: 110±10;
XL: 120±10.	Width(mm):
XS: 78-80/Pass
S: 83-86/Pass
M: 93-96/ Pass
L: 103-106/ Pass
XL:113-116/ Pass
		Finger: ≥0.05;
Palm: ≥0.05	Thickness (mm):
Finger:
0.07-0.10/Pass
			Palm:
0.06-0.07/Pass

ASTM
D5151	Watertightness
Test for
Detection of
Holes	Meet the requirements of ASTM D5151
AQL 2.5	0/125/Pass
ASTM
D6124	Powder
Content	Meet the requirements of ASTM D6124