(260 days)
Not Found
No
The document describes a medical glove, which is a physical product and does not contain any AI models. The text details its composition, testing, and intended use, none of which involve artificial intelligence.
No.
The device is a patient examination glove, intended to prevent contamination between patient and examiner, not to provide therapy.
No
Explanation: The device described is an examination glove, which is a barrier device intended to prevent contamination. It does not perform any diagnostic function.
No
This 510(k) summary describes a physical medical device, specifically "Nitrile Powder Free Examination Gloves." The entire submission focuses on the material properties, physical dimensions, performance against chemical permeation, and biocompatibility of these physical gloves. There is no mention of software components, algorithms, or digital processing.
No
The device is a patient examination glove, which is a barrier device intended to prevent contamination. It does not perform any in vitro diagnostic testing on specimens derived from the human body.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs, fentanyl citrate and gastric acid as per ASTM D6978-05 (2023) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:
The following drugs and concentration had NO breakthrough detected up to 240 minutes:
- Bendamustine HCl (5 mg/mL)
- Bleomycin Sulfate (15 mg/mL)
- Busulfan (6 mg/mL)
- Carboplatin (10 mg/mL)
- Carfilzomib (2 mg/mL)
- Cetuximab (Erbitux) (2 mg/mL)
- Chloroquine (50 mg/mL)
- Cisplatin (1 mg/mL)
- Cladribine (1 mg/mL)
- Cyclophosphamide (20 mg/mL)
- Cyclosporin A (100 mg/mL)
- Cytarabine HCl (100 mg/mL)
- Cytovene (10 mg/mL)
- Dacarbazine (10 mg/mL)
- Daunorubicin HCl (5 mg/mL)
- Decitabine (5 mg/mL)
- Docetaxel (10 mg/mL)
- Doxorubicin HCl (2 mg/mL)
- Epirubicin HCl (2 mg/mL)
- Etoposide (20 mg/mL)
- Fludarabine Phosphate (25 mg/mL)
- Fluorouracil (50 mg/mL)
- Fulvestrant (50 mg/mL)
- Gemcitabine HCl (38 mg/mL)
- Idarubicin HCl (1 mg/mL)
- Ifosfamide (50 mg/mL)
- Irinotecan HCl (20 mg/mL)
- Mechlorethamine HCl (1 mg/mL)
- Melphalan HCl (5 mg/mL)
- MESNA (100 mg/mL)
- Methotrexate (25 mg/mL)
- Mitomycin C (0.5 mg/mL)
- Mitoxantrone HCl (2 mg/mL)
- Oxaliplatin (2 mg/mL)
- Paclitaxel (6 mg/mL)
- Pemetrexed (25 mg/mL)
- Propofol (10 mg/mL)
- Raltitrexed (0.5 mg/mL)
- Retrovir (10 mg/mL)
- Rituximab (10 mg/mL)
- Temsirolimus (25 mg/mL)
- Topotecan HCl (1 mg/mL)
- Triclosan (1 mg/mL)
- Trisenox (Arsenic Trioxide) (1 mg/mL)
- Velcade (Bortezomib) (1 mg/mL)
- Vidaza (Azacitidine) (25 mg/mL)
- Vinblastine Sulfate (1 mg/mL)
- Vincristine Sulfate (1 mg/mL)
- Vinorelbine Tartrate (10 mg/mL)
- Zoledronic Acid (0.8 mg/mL)
The following chemotherapy drugs and concentration showed breakthrough detected in less than 60 minutes:
- Carmustine (3.3 mg/mL), breakthrough detected at 55.5 minutes
- Thiotepa (10 mg/mL), breakthrough detected at 50.8 minutes
Warning: Not recommended for use with Carmustine and Thiotepa
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:
- Fentanyl Citrate Injection (100mcg/2mL)
- Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
Product codes
LZA, LZC, OPJ, QDO
Device Description
The subject device, Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid is a single use, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This product demonstrated reduced potential for sensitizing users to chemical additives, supported by a negative skin sensitization test (Modified Draize-95 Test) and tested for use with chemotherapy drugs, fentanyl citrate and gastric acid.
The gloves are made of nitrile rubber, powder free, ambidextrous with beaded cuff. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that facilitates the user in donning the gloves without using lubricant and donning powder on the glove surface. These gloves are offered in six sizes (XS, S, M, L, XL, XXL), and supplied in non-sterile state.
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 Tests:
The non-clinical performance testing for the Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid demonstrated that the device met acceptance criteria for the following tests:
- Watertight Test (Freedom from Holes) per ASTM D5151-19: Pass (Inspection Level G1, AQL 2.5)
- Physical Properties per ASTM D6319-19: Pass (Before Aging: Tensile strength: min 14MPa, Ultimate elongation: min 500%; After Aging: Tensile strength: min 14MPa, Ultimate elongation: min 400%)
- Dimensions per ASTM D6319-19: Pass (Length: XS: min 220mm, S: min 220mm, M: min 230mm, L: min 230mm, XL: min 230mm, XXL: min 230mm; Palm Width: XS: 70 ± 10mm, S: 80 ± 10mm, M: 95 ± 10mm, L: 110 ± 10mm, XL: 120 ± 10mm, XXL: 130 ± 10mm; Thickness: Finger: min 0.05mm, Palm: min 0.05mm)
- Residual Powder Content per ASTM D6124-06: Pass (Residual powder
§ 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.
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 17, 2025
KL-Kepong Rubber Products SDN. BHD.
Phooi Yann Cheng
Senior Technical Manager
Lot 134905, ¾ Mile Off Jalan Bercham
Kawasan Perindustrian Bercham
Ipoh, Perak 31400
Malaysia
Re: K243133
Trade/Device Name: Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid
Regulation Number: 21 CFR 880.6250
Regulation Name: Non-powdered patient examination glove
Regulatory Class: Class I, reserved
Product Code: LZA, LZC, OPJ, QDO
Dated: June 16, 2025
Received: June 16, 2025
Dear Phooi Yann Cheng:
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 (the 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 available 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.
Page 2
K243133 - Phooi Yann Cheng Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K243133 - Phooi Yann Cheng Page 3
assistance/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,
ALLAN GUAN -S
For Bifeng Qian, M.D., Ph.D.
Assistant Director
DHT4C: Division of Infection Control Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
Indications for Use
See PRA Statement below.
510(k) Number (if known)
K243133
Device Name
Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs, fentanyl citrate and gastric acid as per ASTM D6978-05 (2023) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:
The following drugs and concentration had NO breakthrough detected up to 240 minutes:
- Bendamustine HCl (5 mg/mL)
- Bleomycin Sulfate (15 mg/mL)
- Busulfan (6 mg/mL)
- Carboplatin (10 mg/mL)
- Carfilzomib (2 mg/mL)
- Cetuximab (Erbitux) (2 mg/mL)
- Chloroquine (50 mg/mL)
- Cisplatin (1 mg/mL)
- Cladribine (1 mg/mL)
- Cyclophosphamide (20 mg/mL)
- Cyclosporin A (100 mg/mL)
- Cytarabine HCl (100 mg/mL)
- Cytovene (10 mg/mL)
- Dacarbazine (10 mg/mL)
- Daunorubicin HCl (5 mg/mL)
- Decitabine (5 mg/mL)
- Docetaxel (10 mg/mL)
- Doxorubicin HCl (2 mg/mL)
- Epirubicin HCl (2 mg/mL)
- Etoposide (20 mg/mL)
- Fludarabine Phosphate (25 mg/mL)
- Fluorouracil (50 mg/mL)
- Fulvestrant (50 mg/mL)
- Gemcitabine HCl (38 mg/mL)
- Idarubicin HCl (1 mg/mL)
- Ifosfamide (50 mg/mL)
- Irinotecan HCl (20 mg/mL)
- Mechlorethamine HCl (1 mg/mL)
- Melphalan HCl (5 mg/mL)
- MESNA (100 mg/mL)
- Methotrexate (25 mg/mL)
- Mitomycin C (0.5 mg/mL)
- Mitoxantrone HCl (2 mg/mL)
- Oxaliplatin (2 mg/mL)
- Paclitaxel (6 mg/mL)
- Pemetrexed (25 mg/mL)
FORM FDA 3881 (6/20) Page 1 of 2 PSC Publishing Services (301) 443-6740 EF
Page 5
- Propofol (10 mg/mL)
- Raltitrexed (0.5 mg/mL)
- Retrovir (10 mg/mL)
- Rituximab (10 mg/mL)
- Temsirolimus (25 mg/mL)
- Topotecan HCl (1 mg/mL)
- Triclosan (1 mg/mL)
- Trisenox (Arsenic Trioxide) (1 mg/mL)
- Velcade (Bortezomib) (1 mg/mL)
- Vidaza (Azacitidine) (25 mg/mL)
- Vinblastine Sulfate (1 mg/mL)
- Vincristine Sulfate (1 mg/mL)
- Vinorelbine Tartrate (10 mg/mL)
- Zoledronic Acid (0.8 mg/mL)
The following chemotherapy drugs and concentration showed breakthrough detected in less than 60 minutes:
- Carmustine (3.3 mg/mL), breakthrough detected at 55.5 minutes
- Thiotepa (10 mg/mL), breakthrough detected at 50.8 minutes
Warning: Not recommended for use with Carmustine and Thiotepa
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:
- Fentanyl Citrate Injection (100mcg/2mL)
- Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
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."
FORM FDA 3881 (6/20) Page 2 of 2
Page 6
KL-KEPONG RUBBER PRODUCTS SDN. BHD. K243133
1 of 12
510(k) SUMMARY
Date Summary Prepared: 17 June 2025
1. Submitter's Identification:
KL-KEPONG RUBBER PRODUCTS SDN. BHD.
Lot 134905, ¾ Mile Off Jalan Bercham,
Kawasan Perindustrian Bercham,
31400 Ipoh, Perak, Malaysia.
Contact: Cheng Phooi Yann
Tel: +605-541 7337
Email: py.cheng@klkrp.com.my
2. Name of the Device:
Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid
3. Regulatory Information:
Product Code, Regulation Name: LZA, Polymer Patient Examination Glove
LZC, Medical Glove, Specialty
OPJ, Medical Gloves with Chemotherapy Labeling Claims - Test for Use With Chemotherapy Drugs
QDO, Fentanyl And Other Opioid Protection Glove
Regulatory Class: Class I
Regulation Number: 21 CFR 880.6250
Panel: General Hospital
4. Predicate Device Information:
Predicate Device: K231938
Trade/Device Name: Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid
Device Classification Name: Polymer Patient Examination Glove
Device Class: Class I
Product Code: LZA, LZC, OPJ, QDO
Applicant Name: O&M Halyard, Inc.
Page 7
KL-KEPONG RUBBER PRODUCTS SDN. BHD. K243133
510(k) SUMMARY
Date Summary Prepared: 17 June 2025
1. Submitter's Identification:
KL-KEPONG RUBBER PRODUCTS SDN. BHD.
Lot 134905, ¾ Mile Off Jalan Bercham,
Kawasan Perindustrian Bercham,
31400 Ipoh, Perak, Malaysia.
Contact: Cheng Phooi Yann
Tel: +605-541 7337
Email: py.cheng@klkrp.com.my
2. Name of the Device:
Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid
3. Regulatory Information:
Product Code, Regulation Name: LZA, Polymer Patient Examination Glove
LZC, Medical Glove, Specialty
OPJ, Medical Gloves with Chemotherapy Labeling Claims - Test for Use With Chemotherapy Drugs
QDO, Fentanyl And Other Opioid Protection Glove
Regulatory Class: Class I
Regulation Number: 21 CFR 880.6250
Panel: General Hospital
4. Predicate Device Information:
Predicate Device: K231938
Trade/Device Name: Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid
Device Classification Name: Polymer Patient Examination Glove
Device Class: Class I
Product Code: LZA, LZC, OPJ, QDO
Applicant Name: O&M Halyard, Inc.
1 of 12
Page 8
KL-KEPONG RUBBER PRODUCTS SDN. BHD. K243133
2 of 12
The following drugs and concentration had NO breakthrough detected up to 240 minutes:
- Bendamustine HCl (5 mg/mL)
- Bleomycin Sulfate (15 mg/mL)
- Busulfan (6 mg/mL)
- Carboplatin (10 mg/mL)
- Carfilzomib (2 mg/mL)
- Cetuximab (Erbitux) (2 mg/mL)
- Chloroquine (50 mg/mL)
- Cisplatin (1 mg/mL)
- Cladribine (1 mg/mL)
- Cyclophosphamide (20 mg/mL)
- Cyclosporin A (100 mg/mL)
- Cytarabine HCl (100 mg/mL)
- Cytovene (10 mg/mL)
- Dacarbazine (10 mg/mL)
- Daunorubicin HCl (5 mg/mL)
- Decitabine (5 mg/mL)
- Docetaxel (10 mg/mL)
- Doxorubicin HCl (2 mg/mL)
5. Device Description:
The subject device, Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid is a single use, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This product demonstrated reduced potential for sensitizing users to chemical additives, supported by a negative skin sensitization test (Modified Draize-95 Test) and tested for use with chemotherapy drugs, fentanyl citrate and gastric acid.
The gloves are made of nitrile rubber, powder free, ambidextrous with beaded cuff. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that facilitates the user in donning the gloves without using lubricant and donning powder on the glove surface. These gloves are offered in six sizes (XS, S, M, L, XL, XXL), and supplied in non-sterile state.
6. Indications for Use:
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs, fentanyl citrate and gastric acid as per ASTM D6978-05 (2023) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:
Page 9
KL-KEPONG RUBBER PRODUCTS SDN. BHD. K243133
5. Device Description:
The subject device, Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid is a single use, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This product demonstrated reduced potential for sensitizing users to chemical additives, supported by a negative skin sensitization test (Modified Draize-95 Test) and tested for use with chemotherapy drugs, fentanyl citrate and gastric acid.
The gloves are made of nitrile rubber, powder free, ambidextrous with beaded cuff. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that facilitates the user in donning the gloves without using lubricant and donning powder on the glove surface. These gloves are offered in six sizes (XS, S, M, L, XL, XXL), and supplied in non-sterile state.
6. Indications for Use:
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs, fentanyl citrate and gastric acid as per ASTM D6978-05 (2023) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:
The following drugs and concentration had NO breakthrough detected up to 240 minutes:
- Bendamustine HCl (5 mg/mL)
- Bleomycin Sulfate (15 mg/mL)
- Busulfan (6 mg/mL)
- Carboplatin (10 mg/mL)
- Carfilzomib (2 mg/mL)
- Cetuximab (Erbitux) (2 mg/mL)
- Chloroquine (50 mg/mL)
- Cisplatin (1 mg/mL)
- Cladribine (1 mg/mL)
- Cyclophosphamide (20 mg/mL)
- Cyclosporin A (100 mg/mL)
- Cytarabine HCl (100 mg/mL)
- Cytovene (10 mg/mL)
- Dacarbazine (10 mg/mL)
- Daunorubicin HCl (5 mg/mL)
- Decitabine (5 mg/mL)
- Docetaxel (10 mg/mL)
- Doxorubicin HCl (2 mg/mL)
2 of 12
Page 10
KL-KEPONG RUBBER PRODUCTS SDN. BHD. K243133
3 of 12
- Epirubicin HCl (2 mg/mL)
- Etoposide (20 mg/mL)
- Fludarabine Phosphate (25 mg/mL)
- Fluorouracil (50 mg/mL)
- Fulvestrant (50 mg/mL)
- Gemcitabine HCl (38 mg/mL)
- Idarubicin HCl (1 mg/mL)
- lfosfamide (50 mg/mL)
- Irinotecan HCl (20 mg/mL)
- Mechlorethamine HCl (1 mg/mL)
- Melphalan HCl (5 mg/mL)
- MESNA (100 mg/mL)
- Methotrexate (25 mg/mL)
- Mitomycin C (0.5 mg/mL)
- Mitoxantrone HCl (2 mg/mL)
- Oxaliplatin (2 mg/mL)
- Paclitaxel (6 mg/mL)
- Pemetrexed (25 mg/mL)
- Propofol (10 mg/mL)
- Raltitrexed (0.5 mg/mL)
- Retrovir (10 mg/mL)
- Rituximab (10 mg/mL)
- Temsirolimus (25 mg/mL)
- Topotecan HCl (1 mg/mL)
- Triclosan (1 mg/mL)
- Trisenox (Arsenic Trioxide) (1 mg/mL)
- Velcade (Bortezomib) (1 mg/mL)
- Vidaza (Azacitidine) (25 mg/mL)
- Vinblastine Sulfate (1 mg/mL)
- Vincristine Sulfate (1 mg/mL)
- Vinorelbine Tartrate (10 mg/mL)
- Zoledronic Acid (0.8 mg/mL)
The following chemotherapy drugs and concentration showed breakthrough detected in less than 60 minutes:
- Carmustine (3.3 mg/mL), breakthrough detected at 55.5 minutes
- Thiotepa (10 mg/mL), breakthrough detected at 50.8 minutes
Warning: Not recommended for use with Carmustine and Thiotepa
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:
- Fentanyl Citrate Injection (100mcg/2mL)
- Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
Page 11
KL-KEPONG RUBBER PRODUCTS SDN. BHD. K243133
3 of 12
- Epirubicin HCl (2 mg/mL)
- Etoposide (20 mg/mL)
- Fludarabine Phosphate (25 mg/mL)
- Fluorouracil (50 mg/mL)
- Fulvestrant (50 mg/mL)
- Gemcitabine HCl (38 mg/mL)
- Idarubicin HCl (1 mg/mL)
- Ifosfamide (50 mg/mL)
- Irinotecan HCl (20 mg/mL)
- Mechlorethamine HCl (1 mg/mL)
- Melphalan HCl (5 mg/mL)
- MESNA (100 mg/mL)
- Methotrexate (25 mg/mL)
- Mitomycin C (0.5 mg/mL)
- Mitoxantrone HCl (2 mg/mL)
- Oxaliplatin (2 mg/mL)
- Paclitaxel (6 mg/mL)
- Pemetrexed (25 mg/mL)
- Propofol (10 mg/mL)
- Raltitrexed (0.5 mg/mL)
- Retrovir (10 mg/mL)
- Rituximab (10 mg/mL)
- Temsirolimus (25 mg/mL)
- Topotecan HCl (1 mg/mL)
- Triclosan (1 mg/mL)
- Trisenox (Arsenic Trioxide) (1 mg/mL)
- Velcade (Bortezomib) (1 mg/mL)
- Vidaza (Azacitidine) (25 mg/mL)
- Vinblastine Sulfate (1 mg/mL)
- Vincristine Sulfate (1 mg/mL)
- Vinorelbine Tartrate (10 mg/mL)
- Zoledronic Acid (0.8 mg/mL)
The following chemotherapy drugs and concentration showed breakthrough detected in less than 60 minutes:
- Carmustine (3.3 mg/mL), breakthrough detected at 55.5 minutes
- Thiotepa (10 mg/mL), breakthrough detected at 50.8 minutes
Warning: Not recommended for use with Carmustine and Thiotepa
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:
- Fentanyl Citrate Injection (100mcg/2mL)
- Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
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7. Comparison to the 510(k) Cleared Devices (Predicate Devices):
Table 1: Comparison to Predicate Device
| COMPARISON CRITERIA | Subject Device | Predicate Device (K231938) | COMPARISON RESULTS |
|---|---|---|---|
| Manufacturer | KL-Kepong Rubber Products Sdn. Bhd. | O&M Halyard, Inc. | N/A |
| Device Name | Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid | Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid | Similar |
| Device Classification Name/ Regulation Number | Polymer Patient Examination Glove/ 21 CFR Part 880.6250 | Polymer Patient Examination Glove/ 21 CFR Part 880.6250 | Similar |
| Product Code | LZA, LZC, OPJ, QDO | LZA, LZC, OPJ, QDO | Similar |
| Indications For Use | A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, fentanyl citrate and gastric acid as per ASTM D6978-05 (2023) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. | The device with Low Dermatitis Potential, Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, fentanyl citrate and gastric acid as listed on the label. | Similar |
| Material | Nitrile | Nitrile | Similar |
| Powdered or powder free | Powder free | Powder free | Same |
| Single use | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Same |
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7. Comparison to the 510(k) Cleared Devices (Predicate Devices):
Table 1: Comparison to Predicate Device
| COMPARISON CRITERIA | Subject Device | Predicate Device (K231938) | COMPARISON RESULTS |
|---|---|---|---|
| Manufacturer | KL-Kepong Rubber Products Sdn. Bhd. | O&M Halyard, Inc. | N/A |
| Device Name | Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid | Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid | Similar |
| Device Classification Name/ Regulation Number | Polymer Patient Examination Glove/ 21 CFR Part 880.6250 | Polymer Patient Examination Glove/ 21 CFR Part 880.6250 | Similar |
| Product Code | LZA, LZC, OPJ, QDO | LZA, LZC, OPJ, QDO | Similar |
| Indications For Use | A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, fentanyl citrate and gastric acid as per ASTM D6978-05 (2023) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. | The device with Low Dermatitis Potential, Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, fentanyl citrate and gastric acid as listed on the label. | Similar |
| Material | Nitrile | Nitrile | Similar |
| Powdered or powder free | Powder free | Powder free | Same |
| Single use | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Same |
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| Color | Blue-Green | Grey | Different |
| Dimensions | Meet requirements of ASTM D6319 (XS, S, M, L, XL, XXL) | Meet requirements of ASTM D6319 (XS, S, M, L, XL) | Similar (Additional size XXL for subject device) |
| Physical properties | Meet requirements of ASTM D6319 | Meet requirements of ASTM D6319 | Similar |
| Freedom from Holes | Meet requirements of ASTM D5151 | Meet requirements of ASTM D5151 | Similar |
| Residual Powder | Meet requirements of ASTM D6124 | Meet requirements of ASTM D6124 | Similar |
| Chemotherapy Drugs Permeation Test as per ASTM D6978-05, minimum breakthrough detection time in minutes | 54 drugs were tested | 52 drugs were tested | Minimum 9 drugs were tested. Similar |
Detailed Drug Testing Results:
| Drug | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Azacitidine (Vidaza) (25 mg/mL) | Not tested | > 240 | Not to be claimed |
| Bendamustine HCl (5 mg/mL) | > 240 | > 240 | Same |
| Bleomycin Sulfate (15 mg/mL) | > 240 | (Blenoxane) (15 mg/mL): > 240 | Same |
| Bortezomib (Velcade) (1 mg/mL) | Not tested | > 240 | Not to be claimed |
| Busulfan (6 mg/mL) | > 240 | > 240 | Same |
| Capecitabine (26 mg/mL) | Not Tested | > 240 | Not to be claimed |
| Carboplatin (10 mg/mL) | > 240 | > 240 | Same |
| Carfilzomib (2 mg/mL) | > 240 | > 240 | Same |
| Carmustine (3.3 mg/ml) | 55.5 | 22.9 | 240 |
| Chloroquine | > 240 | Not Tested | Additional test for |
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| (50 mg/mL) | > 240 | (50 mg/mL): Not Tested | subject device |
| Cisplatin (1 mg/mL) | > 240 | > 240 | Same |
| Cladribine (1 mg/mL) | > 240 | > 240 | Same |
| Cyclophosphamide (20 mg/mL) | > 240 | > 240 | Same |
| Cyclosporin A (100 mg/mL) | > 240 | Not Tested | Additional test for subject device |
| Cytarabine HCl (100 mg/mL) | > 240 | (Cytosine) (100 mg/mL): > 240 | Same |
| Cytovene (10 mg/mL) | > 240 | Not Tested | Additional test for subject device |
| Dacarbazine (10 mg/mL) | > 240 | (DTIC) (10 mg/mL): > 240 | Same |
| Dactinomycin (0.5 mg/mL) | Not Tested | > 240 | Not to be claimed |
| Daunorubicin HCl (5 mg/mL) | > 240 | > 240 | Same |
| Decitabine (5 mg/mL) | > 240 | > 240 | Same |
| Docetaxel (10 mg/mL) | > 240 | Not Tested | Additional test for subject device |
| Docetaxel HCl (20 mg/mL) | Not Tested | > 240 | Not to be claimed |
| Doxorubicin HCl (2 mg/mL) | > 240 | (2mg/mL): > 240 | Same |
| Epirubicin HCl (2 mg/mL) | > 240 | (Ellence) (2mg/mL): > 240 | Same |
| Etoposide (20 mg/mL) | > 240 | (20mg/mL): > 240 | Same |
| Floxuridine | > 240 | Not Tested | Not to be claimed |
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| (50 mg/mL) | > 240 | (50 mg/mL): Not Tested | subject device |
| Cisplatin (1 mg/mL) | > 240 | > 240 | Same |
| Cladribine (1 mg/mL) | > 240 | > 240 | Same |
| Cyclophosphamide (20 mg/mL) | > 240 | > 240 | Same |
| Cyclosporin A (100 mg/mL) | > 240 | Not Tested | Additional test for subject device |
| Cytarabine HCl (100 mg/mL) | > 240 | (Cytosine) (100 mg/mL): > 240 | Same |
| Cytovene (10 mg/mL) | > 240 | Not Tested | Additional test for subject device |
| Dacarbazine (10 mg/mL) | > 240 | (DTIC) (10 mg/mL): > 240 | Same |
| Dactinomycin (0.5 mg/mL) | Not Tested | > 240 | Not to be claimed |
| Daunorubicin HCl (5 mg/mL) | > 240 | > 240 | Same |
| Decitabine (5 mg/mL) | > 240 | > 240 | Same |
| Docetaxel (10 mg/mL) | > 240 | Not Tested | Additional test for subject device |
| Docetaxel HCl (20 mg/mL) | Not Tested | > 240 | Not to be claimed |
| Doxorubicin HCl (2 mg/mL) | > 240 | (2mg/mL): > 240 | Same |
| Epirubicin HCl (2 mg/mL) | > 240 | (Ellence) (2mg/mL): > 240 | Same |
| Etoposide (20 mg/mL) | > 240 | (20mg/mL): > 240 | Same |
| Floxuridine | > 240 | Not Tested | Not to be claimed |
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| (100mg/mL): Not Tested | (100mg/mL): > 240 | |
| Fludarabine Phosphate (25 mg/mL): > 240 | Fludarabine Phosphate (25 mg/mL): Not Tested | Additional test for subject device |
| Fluorouracil (50 mg/mL): > 240 | 5-Fluorouracil (50 mg/mL): > 240 | Same |
| Fulvestrant (50 mg/mL): > 240 | Fulvestrant (50 mg/mL): Not Tested | Additional test for subject device |
| Gemcitabine HCl (38 mg/mL): > 240 | Gemcitabine HCl (38 mg/mL): > 240 | Same |
| Idarubicin HCl (1 mg/mL): > 240 | Idarubicin HCl (1 mg/mL): > 240 | Same |
| lfosfamide (50 mg/mL): > 240 | lfosfamide (IFEX) (50 mg/mL): > 240 | Same |
| Irinotecan HCl (20 mg/mL): > 240 | Irinotecan HCl (20 mg/mL): > 240 | Same |
| Lenvatinib (20mg/mL): Not Tested | Lenvatinib (20mg/mL): > 240 | Not to be claimed |
| Leuprolide Acetate Salt (5 mg/mL): Not Tested | Leuprolide Acetate Salt (5 mg/mL): > 240 | Not to be claimed |
| Mechlorethamine HCl (1 mg/mL): > 240 | Mechlorethamine HCl (1 mg/mL): > 240 | Same |
| Melphalan HCl (5 mg/mL): > 240 | Melphalan HCl (5 mg/mL): > 240 | Same |
| MESNA (100 mg/mL): > 240 | MESNA (100 mg/mL): Not Tested | Additional test for subject device |
| Methotrexate (25 mg/mL): > 240 | Methotrexate (25 mg/mL): > 240 | Same |
| Mitomycin C (0.5 mg/mL): > 240 | Mitomycin C (0.5 mg/mL): > 240 | Same |
| Mitoxantrone HCl (2 mg/mL): > 240 | Mitoxantrone HCl (2 mg/mL): > 240 | Same |
| Nelarabine | Nelarabine | Not to be claimed |
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| (100mg/mL): Not Tested | (100mg/mL): > 240 | |
| Fludarabine Phosphate (25 mg/mL): > 240 | Fludarabine Phosphate (25 mg/mL): Not Tested | Additional test for subject device |
| Fluorouracil (50 mg/mL): > 240 | 5-Fluorouracil (50 mg/mL): > 240 | Same |
| Fulvestrant (50 mg/mL): > 240 | Fulvestrant (50 mg/mL): Not Tested | Additional test for subject device |
| Gemcitabine HCl (38 mg/mL): > 240 | Gemcitabine HCl (38 mg/mL): > 240 | Same |
| Idarubicin HCl (1 mg/mL): > 240 | Idarubicin HCl (1 mg/mL): > 240 | Same |
| Ifosfamide (50 mg/mL): > 240 | Ifosfamide (IFEX) (50 mg/mL): > 240 | Same |
| Irinotecan HCl (20 mg/mL): > 240 | Irinotecan HCl (20 mg/mL): > 240 | Same |
| Lenvatinib (20mg/mL): Not Tested | Lenvatinib (20mg/mL): > 240 | Not to be claimed |
| Leuprolide Acetate Salt (5 mg/mL): Not Tested | Leuprolide Acetate Salt (5 mg/mL): > 240 | Not to be claimed |
| Mechlorethamine HCl (1 mg/mL): > 240 | Mechlorethamine HCl (1 mg/mL): > 240 | Same |
| Melphalan HCl (5 mg/mL): > 240 | Melphalan HCl (5 mg/mL): > 240 | Same |
| MESNA (100 mg/mL): > 240 | MESNA (100 mg/mL): Not Tested | Additional test for subject device |
| Methotrexate (25 mg/mL): > 240 | Methotrexate (25 mg/mL): > 240 | Same |
| Mitomycin C (0.5 mg/mL): > 240 | Mitomycin C (0.5 mg/mL): > 240 | Same |
| Mitoxantrone HCl (2 mg/mL): > 240 | Mitoxantrone HCl (2 mg/mL): > 240 | Same |
| Nelarabine | Nelarabine | Not to be claimed |
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| (5 mg/mL): Not Tested | (5 mg/mL): > 240 | |
| Oxaliplatin (2 mg/mL): > 240 | Oxaliplatin (5 mg/mL): > 240 | Same |
| Paclitaxel (6 mg/mL): > 240 | Paclitaxel (Taxol) (6 mg/mL): > 240 | Same |
| Pemetrexed (25 mg/mL): > 240 | Pemetrexed (25 mg/mL): > 240 | Same |
| Propofol (10 mg/mL): > 240 | Propofol (10 mg/mL): Not Tested | Additional test for subject device |
| Raltitrexed (0.5 mg/mL): > 240 | Raltitrexed (0.5 mg/mL): > 240 | Same |
| Retrovir (10 mg/mL): > 240 | Retrovir (10 mg/mL): Not Tested | Additional test for subject device |
| Rituximab (10 mg/mL): > 240 | Rituximab (10 mg/mL): Not Tested | Additional test for subject device |
| Sorafenib Tosylate (200 mg/mL): Not Tested | Sorafenib Tosylate (200 mg/mL): > 240 | Not to be claimed |
| Streptozocin (l00mg/mL): Not Tested | Streptozocin (l00mg/mL): > 240 | Not to be claimed |
| Tamoxifen (2 mg/mL): Not Tested | Tamoxifen (2 mg/mL): > 240 | Not to be claimed |
| Teniposide (10 mg/mL): Not Tested | Teniposide (10 mg/mL): > 240 | Not to be claimed |
| Temsirolimus (25 mg/mL): > 240 | Temsirolimus (25 mg/mL): Not Tested | Additional test for subject device |
| Thiotepa (10 mg/mL): 50.8 | Thiotepa (10 mg/mL): 37.1 | 240 | Topotecan HCl (1 mg/mL): > 240 | Same |
| Triclosan (1 mg/mL): > 240 | Triclosan (1 mg/mL): Not Tested | Additional test for subject device |
| Trisenox (Arsenic Trioxide) | Trisenox (Arsenic | Same |
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| (1 mg/mL): > 240 | Trioxide) (1 mg/mL): > 240 | |
| Velcade (Bortezomib) (1 mg/mL): > 240 | Velcade (Bortezomib) (1 mg/mL): Not Tested | Additional test for subject device |
| Vidaza (Azacitidine) (25 mg/mL): > 240 | Vidaza (Azacitidine) (25 mg/mL): Not Tested | Additional test for subject device |
| Vinblastine Sulfate (1 mg/mL): > 240 | Vinblastine Sulfate (1 mg/mL): > 240 | Same |
| Vincristine Sulfate (1 mg/mL): > 240 | Vincristine Sulfate (Oncovin) (1 mg/mL): > 240 | Same |
| Vinorelbine Tartrate (10 mg/mL): > 240 | Vinorelbine (10 mg/mL): > 240 | Same |
| Zoledronic Acid (0.8 mg/mL): > 240 | Zoledronic Acid (0.8 mg/mL): Not Tested | Additional test for subject device |
| Fentanyl Citrate Injection (100 mcg/2 mL): > 240 | Fentanyl Citrate Injection (100 mcg/2 mL): > 240 | Same |
| Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution: > 240 | Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution: > 240 | Same |
Biocompatibility Testing:
| Biocompatibility ISO 10993-10:2021 Biological Evaluation of Medical Devices – Part 10: Tests for Skin Sensitization | Under the conditions of the study, not a skin sensitizer. | Under the conditions of the study, the test article was considered non-sensitizing. | Same |
| Biocompatibility ISO 10993-11:2017 Biological Evaluation of Medical Devices- Part 11: Tests for Systemic Toxicity | Under the conditions of the study, the test article did not elicit acute systemic toxicity. | Under the conditions of the study, the test article did not elicit acute systemic toxicity. | Same |
| Biocompatibility ISO 10993-23:2021 Biological Evaluation of Medical Devices – Part 10: Tests for Irritation | Under the conditions of the study, not an irritant. | Under the conditions of the study, the test article was considered non-irritating. | Same |
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| Clinical Test (Modified Draize-95 Test) | Under the conditions of the study, device was nonirritating and showed no clinical evidence of residual chemical additives that may induce Type IV allergy in human subject. | Under the conditions of the study, device was nonirritating and showed no clinical evidence of residual chemical additives that may induce Type IV allergy in human subject. | Same |
8. Summary of Non-Clinical Tests Performed:
The non-clinical performance testing completed for the KL-Kepong Rubber Products Sdn. Bhd., Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid demonstrated that the subject device met the acceptance criteria or specification for the applicable test methodology or standard as shown below.
Table 2: Summary Non-Clinical Tests
| Standard | Testing | Requirements | Result |
|---|---|---|---|
| ASTM D5151-19 | Watertight Test (Freedom from Holes) | Pass Inspection Level G1, AQL 2.5 | Pass |
| ASTM D6319-19 | Physical Properties | Before Aging: Tensile strength: min 14MPa, Ultimate elongation: min 500%. After Aging: Tensile strength: min 14MPa, Ultimate elongation: min 400% | Pass |
| ASTM D6319-19 | Dimensions | Length: XS: min 220mm, S: min 220mm, M: min 230mm, L: min 230mm, XL: min 230mm, XXL: min 230mm. Palm Width: XS: 70 ± 10mm, S: 80 ± 10mm, M: 95 ± 10mm, L: 110 ± 10mm, XL: 120 ± 10mm, XXL: 130 ± 10mm. Thickness: Finger: min 0.05mm | Pass |
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| | Palm: min 0.05mm | |
| ASTM D6124-06 | Residual Powder Content | Residual powder