Who is the manufacturer of Powder Free Nitrile Examination Gloves, Blue Chemotest?

Careglove Global Sdn. Bhd. filed the 510(k) submission for Powder Free Nitrile Examination Gloves, Blue Chemotest (K211666).

What is the FDA product code for Powder Free Nitrile Examination Gloves, Blue Chemotest?

LZA. It is classified under 21 CFR 880.6250 as a Class 1 device in the General Hospital panel.

What is the regulatory pathway for Powder Free Nitrile Examination Gloves, Blue Chemotest?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Powder Free Nitrile Examination Gloves, Blue Chemotest?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Powder Free Nitrile Examination Gloves, Blue Chemotest

K211666 · Careglove Global Sdn. Bhd. · LZA · Jan 9, 2022 · General Hospital

Device Facts

Record ID	K211666
Device Name	Powder Free Nitrile Examination Gloves, Blue Chemotest
Applicant	Careglove Global Sdn. Bhd.
Product Code	LZA · General Hospital
Decision Date	Jan 9, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6250
Device Class	Class 1

Intended Use

A 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.

Device Story

Disposable, non-sterile, ambidextrous, powder-free nitrile examination glove; beaded cuff design. Manufactured via on-line polymer-coating and mild chlorination to modify surface characteristics for tack-free donning. Used by healthcare professionals in clinical settings to provide a barrier against contamination. Tested for permeation resistance against various chemotherapy drugs per ASTM D6978-05; provides specific breakthrough times for agents including Cisplatin, Cyclophosphamide, and others. Not recommended for Carmustine or ThioTepa due to low permeation times. Protects both patient and examiner during medical examinations and handling of hazardous chemotherapy agents.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM D6319-19 (dimensions, physical properties, water leak test, powder residue) and ASTM D6978-05 (chemotherapy drug permeation). Biocompatibility testing performed per ISO 10993-10 (skin irritation, sensitization), ISO 10993-5 (cytotoxicity), and ISO 10993-11 (acute systemic toxicity).

Technological Characteristics

Material: Nitrile. Design: Powder-free, non-sterile, ambidextrous, beaded cuff. Surface treatment: On-line polymer-coating and mild chlorination. Standards: ASTM D6319-19 (dimensions, physical properties), ASTM D5151-19 (water leak), ASTM D6124-06 (powder residue), ASTM D6978-05 (chemo permeation). Biocompatibility: ISO 10993-5, 10, 11. Connectivity: None. Energy source: None.

Indications for Use

Indicated for use as a disposable medical device worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with specific chemotherapy drugs per ASTM D6978-05.

Regulatory Classification

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.

Predicate Devices

Careplus Powder Free Nitrile Examination Glove, Blue, Chemotest (K162858)

Related Devices

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K243792 — Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White) · Basic Medical Technology, Inc. · Feb 18, 2025
K240545 — GenaCheck Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL) · Genabio Diagnostics, Inc. · Aug 28, 2024
K212408 — Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid) · Pt. Maja Agung Latexindo · May 18, 2022
K223559 — Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) · Nephron Pharmaceuticals Corporation · Feb 9, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 9, 2022 Careglove Global SDN. BHD. Siti Ahmad Official Correspondent Careglove Global SDN BHD Lot 17479, Lorong Senawang 2/3, Off Jalan Senawang 3, Senewang Industrial Estate Seremban, Negeri Sembilan Darul Khusus 70450 Malaysia Re: K211666 Trade/Device Name: Powder Free Nitrile Examination Gloves, Blue Chemotest Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: November 25, 2021 Received: December 6, 2021 Dear Siti Ahmad: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. For Clarence W. Murray III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K211666 Device Name POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, CHEMOTEST Indications for Use (Describe) A 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. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Chemotherapy Drugs Permeation The following chemicals have been tested with these gloves. Chemotherapy Drugs Concentration Breakthrough Detection Time in Minutes *Carmustine (BCNU) 3.3 mg/ml 22.6 Cisplatin Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min Dacarbazine Doxorubicin HCL 2.0 mg/ml >240 min Etoposide 20.0 mg/ml >240 min Fluorouracil 50.0 mg/ml >240 min Ifosfamide 50.0 mg/ml >240 min Mitoxantrone 2 mg/ml >240 min Paclitaxel 6.0 mg/ml >240 min *Thio Tepa 10.0 mg/ml >43.9 Vincristine Sulfate 1.0 mg/ml >240 min * WARNING: Not recommended for use with Carmustine and Thlotepa. Please note that following drugs have extremely low permeation times: Carmustine (BCNU): 22.6 minutes and Thiotepa: 43.9 munites 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}------------------------------------------------ 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." {4}------------------------------------------------ ## 510(K) SUMMARY K211666 #### CAREGLOVE GLOBAL SDN BHD Applicant: - Location Lot 17479, Lorong Senawang 2/3 Off Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan Darul Khusus, Malaysia. Phone No. (60) 6 6782377 Fax No. (60) 6 6785377 Contact Person: Lim Kwee Shyan Summary Preparation Date: 5th January, 2021 Device Information Trade Name:POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, CHEMOTEST Common Name:POWDER FREE NITRILE EXAMINATION GLOVES Classification Name: Patient Examination Gloves Product Code: LZA, LZC Regulation: 21 CFR 880.6250 ### Predicate Device Identification 510(k) Number: K162858, Device Name: Careplus Powder Free Nitrile Examination Glove, Blue, Chemotest #### Device Description It is the powder-free variation of the class I latex patient examination gloves made by on-line polymer-coating and mild on-line chlorination process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. #### Intended Use of Device A 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. # Comparison of technological characteristics between the predicate and subject devices. The Powder Free Nitrile Examination Gloves – Blue, Chemotest, are summarized with the following technological characteristic compared to ASTM D6319 or equivalent standards. | Characteristic | Standard | Specification | Subject Device Powder Free Nitrile Examination Gloves, Blue, Chemotest) K211666 | Predicate Device (Careplus Powder Free Nitrile Examination Glove, Blue, Chemotest) K162858 | Remarks | |----------------|----------|---------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|---------| | Product Code | - | - | LZA, LZC | LZA, LZC | Same | | Intended Use | - | - | Intended for medical purposes that is worn on the examiner's hand to prevent contamination | Intended for medical purposes that is worn on the examiner's hand to prevent | Same | {5}------------------------------------------------ | | | | between patient and examiner | contamination between patient and examiner | | |------------------------|---|---|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Design | - | - | Powder Free, Non- Sterile, Ambidextrous, Beaded Cuff | Powder Free, Non- Sterile, Ambidextrous, Beaded Cuff | Same | | 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 | 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 | Same | | Construction | - | - | Ambidextrous, Polymer Coated or Chlorinated, Powder Free Nitrile | Ambidextrous, Polymer Coated or Chlorinated, Powder Free Nitrile | Same | | Color Description | - | - | Blue | Blue | Similar | | Material | - | - | Nitrile | Nitrile | Same | | Single Use | - | - | Yes | Yes | Same | | Packaging | - | - | Packed in Dispenser Boxes | Packed in Dispenser Boxes | Same | | Chemo Drugs Claim | - | - | Chemo Claim | Chemo Claim | Same | Summary of non-clinical performance test result | Characteristic | Standard | Specification | Subject Device Powder Free Nitrile Examination Gloves, Blue, Chemotest) K211666 | Predicate Device (Careplus Powder Free Nitrile Examination Glove, Blue, Chemotest) K162858 | Remarks | |---------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Dimension | ASTM D6319-19 | | | | Same | | Length (size: XSmall), mm Length (size: Small), mm Length (size: Medium), mm Length (size: Large), mm Length (size: XLarge), mm | | 220 min 220 min 230 min 230 min 230 min | Meet 220mm min Meet 220mm min Meet 230mm min Meet 230mm min Meet 230mm min | Meet 220mm min Meet 220mm min Meet 230mm min Meet 230mm min Meet 230mm min | | | Thickness (palm), mm Thickness (finger), mm | | 0.05 min 0.05 min | Meet 0.05mm min Meet 0.05mm min | Meet 0.05mm min Meet 0.05mm min | | | Width (size: XSmall), mm Width (size: Small), mm Width (size: Medium), mm Width (size: Large), mm Width (size: XLarge), mm | | 70 ± 10 80 ± 10 95 ± 10 110 ± 10 120 ± 10 | Meet 70 ± 10 mm Meet 80 ± 10 mm Meet 95 ± 10 mm Meet 110 ± 10 mm Meet 120 ± 10 mm | Meet 70 ± 10 mm Meet 80 ± 10 mm Meet 95 ± 10 mm Meet 110 ± 10 mm Meet 120 ± 10 mm | | | Physical Properties | ASTM D6319-19 | | | | Similar | | (Before Ageing) i) Tensile Strength (MPa) ii) Ultimate Elongation (%) | | Min. 14 Min. 500 | Meet 14MPa min. Meet 500% min | Meet 14MPa min. Meet 500% min | | | | | | | | | | (After Aging) i) Tensile Strength (MPa) ii) Ultimate Elongation (%) | | Min. 14 Min. 400 | Meets 14MPa min Meet 400% min. | Meets 14MPa min Meet 400% min. | | | Water Leak Test, 1000 ml Before Aging, AQL After Aging, AQL | ASTM D6319-19 ASTM D5151-19 | G- I, AQL 2.5 (FDA GII, AQL 2.5) | Meet AQL 1.5 Meet AQL 2.5 | Meet AQL 1.5 Meet AQL 2.5 | Similar | | Powder Free Residue ASTM D6319-19 Powder Free Residue, ASTM mg/glove D6124-06 | | Max. 2mg/glove | Meet 2mg/glove max. | Meet 2mg/glove max | Similar | | Biocompatibility Test i) Primary Skin Irritation Test | ISO 10993- 10 | No Irritation Animal | i) Primary Skin Irritation Test. Conclusion: Under the conditions of this study the test material did not cause an irritant response | i)Primary Skin Irritation Test. Conclusion: Under the conditions of this study the test material did not cause an irritant response. | Same | | ii)Skin Sensitization Test | ISO 10993- 10 | No Irritation Animal | ii)Dermal Sensitization Test. Conclusion: Under the conditions of this study, the test material did not produce a skin sensitization effect | ii)Dermal Sensitization Test. Conclusion: Under the conditions of this study, the test material did not produce a skin sensitization effect. | Same | | iii) In Vitro Cytotoxicity Test | ISO 10993- 5:2009 | - | iii) In Vitro Cytotoxicity Test. Conclusion: Under condition of this study, test material exhibited moderate cytotoxicity reactivity at 6.0 cm²/mL extract concentrations and no cytotoxicity reactivity at the 3.0 cm²/mL extract concentrations of the test. | iii) No data available | Different | | Iv) Acute Systemic Toxicity | ISO 10993- 11 | - | iv) Acute Systemic Toxicity. Conclusion: Under condition of this study, the test material showed no adverse biological reaction after administration of the sample's extract on the rats during the period of the study. | No data available | Different | | Chemotherapy Drug Permeation Claim | ASTM D6978-05 | - | Carmustine (BCNU) (3.3 mg/ml) - 22.6, Cisplatin (1.0 mg/ml) - >240 min Cyclophosphamide (Cytoxan) (20.0 mg/ml) | Carmustine (BCNU) (3.3 mg/ml) — 10.2 min Cisplatin (1.0 mg/ml) - >240 min, Cyclophosphamide | Similar | {6}------------------------------------------------ {7}------------------------------------------------ | | - >240 min Dacarbazine (10 mg/ml) - >240 min Doxorubicin HCL (2.0 mg/ml) - >240 min Etoposide (20 mg/ml) - >240 min Flurouracil (50 mg/ml) - >240 min Ifosfamide (50.0 mg/ml) - >240 min Mitoxantrone (2 mg/ml) - >240 min Paclitaxel (6.0 mg/ml) - >240 min ThioTepa (10.0 mg/ml) - 43.9 Vincristine Sulfate (1.0 mg/ml) - >240 min | (Cytoxan) (20mg/ml) - >240 min Dacarbazine (10.0 mg/ml) - >240 min Doxorubicin HCL (2.0 mg/ml) - >240 min Etoposide (20.0 mg/ml) - >240 min Flurouracil (50.0 mg/ml) - >240 min Ifosfamide (50 mg/ml) - >240 min, Mitoxantrone (2.0 mg/ml) - >240 min Paclitaxel (6.0 mg/ml) - >240 min ThioTepa (10.0 mg/ml) - >40.5 min Vincristine Sulfate (1.0 mg/ml) - >240 min | |--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| Following is a table showing the actual measured parameters of the gloves (e.g. length, thickness, width, physical properties, etc.) as compare to ASTM. All data meets the standard reference requirement. | Test | Standard | Acceptance Criteria | Result | | | | | | | | | | | | | | | | | | | | | | | | | |----------------------------|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------|---------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|--|--|--|--|--|--|--|--|--|--|--|------|--|--|--|--|--|--|--|--|--|------| | Freedom From Holes | ASTM D6319-19 ASTM D5151-19 | Meet requirement inspection level G-I, AQL 2.5 | Pass | | | | | | | | | | | | | | | | | | | | | | | | | | Dimension | ASTM D6319-19 | Size XSmall Small Medium Large XLarge Length, min. mm 220 230 Thickness, min. mm 0.05 Width, ± 10 mm 70 80 95 110 120 | | | | | | | | | | | | | | | | | | | | | | | | | Pass | | | | Physical Properties | ASTM D6319-19 | Before Aging After Accelerated Aging Tensile Strength Ultimate Elongation Tensile Strength Ultimate Elongation 14 MPa min. 500 % min. 14 MPa min. 400 % min. | | | | | | | | | | | | | Pass | | | | | | | | | | | | Residual Powder Content | ASTM D6319-19 ASTM D6124-06 | | | Not more than 2 mg per glove | Pass | | | | | | | | | | | | | | | | | | | | | | | # Summary of Clinical Testing Not applicable # Conclusions: The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K211666, the Powder Free Nitrile Examination Glove Blue Chemotest is a safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K162858.

Powder Free Nitrile Examination Gloves, Blue Chemotest

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

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Powder Free Nitrile Examination Gloves, Blue Chemotest

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

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Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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