(153 days)
Not Found
No
The device is a disposable examination glove and the description and performance studies focus on material properties and physical characteristics, with no mention of AI or ML.
No
Explanation: A therapeutic device is designed to treat or alleviate a medical condition. This device, examination gloves, is for preventing contamination, not for treating any condition.
No
The device description clearly states it is a "disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner." This indicates its function is protective and preventative, not diagnostic. There is no mention of it being used to identify or analyze diseases, conditions, or injuries.
No
The device is a physical product (gloves) and the summary describes material properties and physical performance tests, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "worn on the examiner's hands to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the physical characteristics of the glove (material, color, size, powder-free) and its purpose as a barrier. There is no mention of analyzing samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition.
- Performance Studies: The performance studies focus on the physical integrity and biocompatibility of the glove, which are relevant for a barrier device, not an IVD.
In summary, the device is a medical glove intended for protection and contamination prevention, not for performing diagnostic tests.
N/A
Intended Use / Indications for Use
The Disposable Nitrile Examination Gloves (Powder free, Purple-Blue, Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
The proposed device, Disposable Nitrile Examination Gloves (Powder free, Purple-Blue, Blue) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size and color. The color of the proposed device is Blue and Purple-Blue.
The proposed device is not provided as sterilized
The proposed device is made of Nitrile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner's, 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)
Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6124-17, Standard Test Method for Residual Powder on Medical Gloves.
ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
Performance Test Results Summary:
- ASTM D5151 (Testing for Freedom from holes):
- Acceptance Criteria: Freedom from holes AQL 2.5
- Results (Blue Color): No water leakage is inspected form 200 samples
- Results (Purple-Blue Color): No water leakage is inspected form 200 samples
- ASTM D6124 (Determine the powder residue for powder free gloves):
- Acceptance Criteria: = 19 MPa; Ultimate Elongation: >= 500%.
- Results (Blue Color - After Aging): Tensile Strength: >= 17.8 MPa; Ultimate Elongation: >= 472%.
- Results (Purple-Blue Color - Before Aging): Tensile Strength: >= 19 MPa; Ultimate Elongation: >= 500%.
- Results (Purple-Blue Color - After Aging): Tensile Strength: >= 17.1 MPa; Ultimate Elongation: >= 463%.
- ASTM D412, ASTM D3767 (Testing For physical dimensions specification):
- Acceptance Criteria: Length: 220 mm min. for size (XS, S); Length: 230 mm min. for size (M, L, XL); Width: 70+/-10 mm for XS; 80+/-10 mm for S; 95+/-10 mm for M; 110+/-10 mm for L; 120+/-10 mm for XL. Cuff Thickness: >=0.05 mm; Finger Thickness: >=0.05 mm; Palm Thickness: >=0.05 mm; All acceptance criteria above meet the requirements in Table 1 Dimensions and Tolerances of ASTM D6319
- Results (Blue Color): Length of Size XS: >= 230 mm; Width of Size XS: 75+/-3 (75-78) mm; Cuff Thickness of Size XS: >=0.06 mm; Palm Thickness of Size XS: >=0.07 mm; Finger Thickness of Size XS: >=0.10 mm. Length of Size S: >= 228mm; Width of Size S: 85+/-2 (85-87) mm; Cuff Thickness of Size S: >=0.06 mm; Palm Thickness of Size S: >=0.07 mm; Finger Thickness of Size S: >=0.10 mm. Length of Size M: >= 240 mm; Width of Size M: 95+/-2 (95-97) mm; Cuff Thickness of Size M: >=0.06 mm; Palm Thickness of Size M: >=0.07 mm; Finger Thickness of Size M: >=0.10 mm. Length of Size L: >= 240 mm; Width of Size L: 105+/-4 (105-109) mm; Cuff Thickness of Size L: >=0.06 mm; Palm Thickness of Size L: >=0.07 mm; Finger Thickness of Size L: >=0.10 mm. Length of Size XL: >= 241 mm; Width of Size XL: 115+/-2 (115-117) mm; Cuff Thickness of Size XL: >=0.06 mm; Palm Thickness of Size XL: >=0.07 mm; Finger Thickness of Size XL: >=0.10 mm
- Results (Purple-Blue Color): Length of Size XS: >= 230 mm; Width of Size XS: 75+/-4 (75-79) mm; Cuff Thickness of Size XS: >=0.05 mm; Palm Thickness of Size XS: >=0.07 mm; Finger Thickness of Size XS: >=0.08 mm. Length of Size S: >= 235mm; Width of Size S: 85+/-2 (85-87) mm; Cuff Thickness of Size S: >=0.05 mm; Palm Thickness of Size S: >=0.05 mm; Finger Thickness of Size S: >=0.08 mm. Length of Size M: >= 236 mm; Width of Size M: 95+/-3 (95-98) mm; Cuff Thickness of Size M: >=0.05 mm; Palm Thickness of Size M: >=0.05 mm; Finger Thickness of Size M: >=0.07 mm. Length of Size L: >= 240 mm; Width of Size L: 105+/-3 (105-108) mm; Cuff Thickness of Size L: >=0.05 mm; Palm Thickness of Size L: >=0.06 mm; Finger Thickness of Size L: >=0.08 mm. Length of Size XL: >= 240 mm; Width of Size XL: 115+/-3 (116-118) mm; Cuff Thickness of Size XL: >=0.05 mm; Palm Thickness of Size XL: >=0.05 mm; Finger Thickness of Size XL: >=0.08 mm.
- ISO 10993-11 (Evaluate the endpoint of Systemic Cytotoxicity for biocompatibility):
- Acceptance Criteria: The test article showed no evidence of systemic toxicity from the extract.
- Results: The test article showed no evidence of systemic toxicity from the extract.
- ISO 10993-10 (Evaluate the endpoint of irritant for biocompatibility):
- Acceptance Criteria: The response of the test article extract is negligible.
- Results: The test result showed that the response of the test article extract was categorized as negligible under the test condition.
- ISO 10993-10 (Evaluate the endpoint of sensitization for biocompatibility):
- Acceptance Criteria: The test article showed no evidence of causing delayed dermal contact sensitization
- Results: The test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 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.
0
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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 26, 2021
Tangshan Lanhai Medical Supplies Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm. 912, Building #15, XiYueHui, No. 5, YiHe North Rd., FangShan District Beijing, Beijing 102401 China
Re: K210898
Trade/Device Name: Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: June 1, 2021 Received: June 4, 2021
Dear Ray 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.
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 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.
For Clarence W. Murray III, 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K210898
Device Name
Disposable Nitrile Examination Gloves (Powder free, Purple-Blue, Blue)
Indications for Use (Describe)
The Disposable Nitrile Examination Gloves (Powder free, Purple-Blue, Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@.fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary K210898
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) Number: K210898
-
- Date of Preparation: 08/24/2021
-
- Sponsor
Tangshan Lanhai Medical Supplies Co., Ltd.
South Side of Zhongda Street, East Side of Jinxiu Road, Chengxi Industrial Zone, Luannan County, Tangshan City, Hebei Province, P.R. China 063500 Contact Person: Li Ruidong Position: Manager Tel: +86-15931581811 Fax: +86-315-4155192 Email: 718356353@qq.com
-
Submission Correspondent 3.
Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China,102401 Tel: +86-18910677558 Fax: +86-10-56335780 Email: ray.wang@believe-med.com -
Proposed Device Identification 4.
Trade Name: Disposable Nitrile Examination Gloves (Powder free, Purple-Blue, Blue) Common Name: NITRILE Patient Examination Gloves (Powder Free) Regulatory Information: Classification: I Product Code: LZA Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital
Indication For Use Statement:
The Disposable Nitrile Examination Gloves (Powder free, Purple-Blue, Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
- న్న Predicate Device Identification
4
510(k) Number: K150340
Product Name: POWDER FREE Nitrile GLOVES (White, Cobalt Blue, Black, Ice Blue) Manufacturer: HEBEI HONGSEN PLASTICS TECHNOLOGY CO., LTD
- Device Description 6.
The proposed device, Disposable Nitrile Examination Gloves (Powder free, Purple-Blue, Blue) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size and color. The color of the proposed device is Blue and Purple-Blue.
The proposed device is not provided as sterilized
The proposed device is made of Nitrile.
| Designation | Size | Tolerance | ||||
|---|---|---|---|---|---|---|
| XS | S | M | L | XL | ||
| Length, mm | 220 | 220 | 230 | 230 | 230 | min |
| Width, mm | 70 | 80 | 95 | 110 | 120 | ±10 |
| Thickness, mm: | ||||||
| Finger | 0.05 | min | ||||
| Palm | 0.05 | min | ||||
| Cuff | 0.05 | min |
Table 1 Device Size Specifications
| Before Aging | After Aging | Pinhole AQL | ||
|---|---|---|---|---|
| Tensile | ||||
| Strength | Ultimate | |||
| Elongation | Tensile | |||
| Strength | Ultimate | |||
| Elongation | ||||
| 14 MPa, min | 500 % min | 14 MPa, min | 400 % min | 2.5 |
Table 2 Performance and Physical Specifications
The above data of size, performance, and physical specifications of proposed gloves meet all the current specifications listed in the ASTM standard D6319.
-
- Comparison of technological characteristics between the subject and predicate devices
| ITEM | Proposed Device (K210898) | Predicate Device (K150340) | Remark |
|---|---|---|---|
| Disposable Nitrile Examination Gloves | |||
| (Powder free, Purple-Blue, Blue) | POWDER FREE Nitrile GLOVES (White, | ||
| Cobalt Blue, Black, Ice Blue) | |||
| Product Code | LZA | LZA | SAME |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | SAME |
Table 1 General Comparison
5
| Class | I | I | SAME | |
|---|---|---|---|---|
| Intended | ||||
| Use/Indication | ||||
| For Use | The Disposable Nitrile Examination Gloves | |||
| (Powder free, Purple-Blue, Blue) is a | ||||
| disposable device intended for medical | ||||
| purposes that is worn on the examiner's | ||||
| hands to prevent contamination between | ||||
| patient and examiner. | The POWDER FREE Nitrile GLOVES | |||
| (White, Cobalt Blue, Black, Ice Blue) is a | ||||
| disposable device intended for medical | ||||
| purposes that is worn on the examiner's | ||||
| hands to prevent contamination between | ||||
| patient and examiner. | SAME | |||
| Powdered or | ||||
| Powered free | Powdered free | Powdered free | SAME |
| Proposed Device (K210898) | Size | Tolerance | ||||||
|---|---|---|---|---|---|---|---|---|
| Disposable Nitrile Examination | ||||||||
| Gloves (Powder free, | ||||||||
| Purple-Blue, Blue) | Designation | XS | S | M | L | XL | ||
| Length, mm | 220 | 220 | 230 | 230 | 230 | min | ||
| Width, mm | 70 | 80 | 95 | 110 | 120 | ±10 | ||
| Thickness, mm: | ||||||||
| Finger | 0.05 | min | ||||||
| Palm | 0.05 | min | ||||||
| Cuff | 0.05 | min | ||||||
| Predicate Device (K150340) | Size | |||||||
| POWDER FREE Nitrile | ||||||||
| GLOVES (White, Cobalt Blue, | ||||||||
| Black, Ice Blue) | Designation | XS | S | M | L | XL | Tolerance | |
| Length, mm | 230 | 230 | 230 | 230 | 230 | min | ||
| Width, mm | 70 | 80 | 95 | 110 | 120 | ±10 | ||
| Thickness, mm: | ||||||||
| Finger | 0.10-0.12 | ±0.03 | ||||||
| Palm | 0.08-0.10 | ±0.03 | ||||||
| Cuff | 0.06-0.09 | ±0.03 | ||||||
| Remark | Similar |
Table 2 Device Dimensions Comparison
Different Analysis:
The proposed device has different size specification to the predicate device, but all proposed devices are meet the specifications of ASTM D 6319.
| ITEM | Proposed Device (K210898)
Disposable Nitrile Examination Gloves
(Powder free, Purple-Blue, Blue) | Predicate Device (K150340)
POWDER FREE Nitrile GLOVES
(White, Cobalt Blue, Black, Ice
Blue) | Remark |
|----------|--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-----------|
| Colorant | Blue, Purple Blue | White, Cobalt Blue, Black, Ice Blue | Different |
| Table 3 Performance Comparison |
|---|
6
| Single Use | Yes | Yes | SAME | ||
|---|---|---|---|---|---|
| Physical | |||||
| Properties | Before | ||||
| Aging | Tensile | ||||
| Strength | 14 MPa, min | 15 MPa, min | Different | ||
| Ultimate | |||||
| Elongation | 500 % min | 500 % min | SAME | ||
| After | |||||
| Aging | Tensile | ||||
| Strength | 14 MPa, min | 14 MPa, min | SAME | ||
| Ultimate | |||||
| Elongation | 400 % min | 400 % min | SAME | ||
| Freedom from Holes | Comply with ASTM D6319 | Comply with ASTM D6319 | SAME | ||
| Be free from holes when tested in | |||||
| accordance with ASTM D5151, AQL | |||||
| 2.5 | Be free from holes when tested in | ||||
| accordance with ASTM D5151, | |||||
| AQL 1.5 | Different | ||||
| Powder Content | Less than 2 mg per glove when tested | ||||
| in accordance with ASTM D6124 | Meet the requirements of ASTM | ||||
| 6124 | SAME |
Different Analysis:
The proposed device has different color to the predicate device, this different may causes potential biocompatibility risk, for this risk we conducted the biocompatibility test according to the ISO 10993-10 and ISO 10993-11 and the test results showed that the proposed devices did not induce skin irritation and showed no significant evidence of causing skin sensitization and systemic toxicity response.
Different Analysis:
The proposed device has different Tensile Strength before aging specification to the predicate device, but all proposed device meets the specification requirements of ASTM D 6319.
Different Analysis:
The proposed device has different AQL to the predicate device, but all proposed device meets the specification requirements of ASTM D 6319.
| ITEM | Proposed Device | Predicate Device (K150340) | Remark | |
|---|---|---|---|---|
| Disposable Nitrile Examination | ||||
| Gloves (Powder free, Purple-Blue, | ||||
| Blue) | POWDER FREE Nitrile GLOVES | |||
| (White, Cobalt Blue, Black, Ice | ||||
| Blue) | ||||
| Material used | Nitrile | Nitrile | SAME | |
| Biocompatibility | Irritation | Under the conditions of the study, | ||
| not an irritant | Under the conditions of the study, | |||
| not an irritant | SAME | |||
| Sensitization | Under conditions of the study, not a | |||
| sensitizer. | Under conditions of the study, not a | |||
| sensitizer. | ||||
| acute | ||||
| systemic | Under the conditions of the study, | |||
| there was no evidence of systemic | Not Available | Different |
| Table 4 Safety Comparisor | |
|---|---|
7
| toxicity | toxicity from the extract. | |||
|---|---|---|---|---|
| Label and Labeling | Meet FDA's Requirements | Meet FDA's Requirements | SAME |
Different Analysis:
The proposed device has conducted the acute systemic toxicity testing, and the test results showed that there was no evidence of systemic toxicity.
8. Summary of Non-Clinical Testing
Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6124-17, Standard Test Method for Residual Powder on Medical Gloves.
ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D5151 | Testing for Freedom | ||
| from holes | Freedom from holes | Blue Color | |
| from holes | AQL 2.5 | No water leakage is inspected form 200 | |
| samples | |||
| Purple-Blue Color | |||
| No water leakage is inspected form 200 | |||
| samples | |||
| ASTM D6124 | Determine the powder |