← Product Code [LZA](/productcode/LZA) · K262542 # Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim (K262542) _Top Glove Sdn. Bhd. · LZA · Sep 9, 2026 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K262542 ## Device Facts - **Applicant:** Top Glove Sdn. Bhd. - **Product Code:** [LZA](/productcode/LZA.md) - **Decision Date:** Sep 9, 2026 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 880.6250 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## Indications for Use Biodegradable Nitrile Powder Free Examination Glove, Green A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim A patient examination glove is a disposable device intended for medical purpose 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 Drug Permeation: The following chemicals have been tested with these gloves. Simulated Gastric Acid Permeation Resistance Claim- Under the testing conditions of ASTM D6978-05, was found to have no breakthrough detected up to 240 minutes. Fentanyl Permeation Resistance Claim- Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2ml) was found to have no breakthrough detected up to 240 minutes. ## Device Story Disposable nitrile examination gloves; worn by healthcare professionals; prevents cross-contamination between patient and examiner. Tested for permeation resistance against 32 chemotherapy drugs, fentanyl citrate, and gastric acid per ASTM D6978-05. Provides barrier protection during medical procedures; specifically evaluated for handling hazardous chemotherapy agents and opioids. Warning provided for specific drugs with low breakthrough times (Carmustine, Thiotepa). ## Clinical Evidence Bench testing only. Permeation testing performed per ASTM D6978-05 for 32 chemotherapy drugs, fentanyl citrate, and simulated gastric acid. Breakthrough detection times reported for all tested substances. ## Technological Characteristics Nitrile material; powder-free; disposable; non-sterile. Tested per ASTM D6978-05 for chemical permeation resistance. ## Regulatory 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. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION September 9, 2026 Top Glove Sdn. Bhd. Noor Akilah Saidin General Manager, Regulatory Affairs Lot 4969, Jalan Teratai, Batu 6, Off Jalan Meru Klang, Selangor 41050 Malaysia Re: K262542 Trade/Device Name: Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim 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: August 24, 2026 Received: August 24, 2026 Dear Noor Akilah Saidin: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K262542 - Noor Akilah Saidin 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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 Management System Regulation (QMSR) (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- {2} K262542 - Noor Akilah Saidin 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 {3} # Indications for Use | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | | K262542 | ? | | --- | --- | --- | --- | | Please provide the device trade name(s). | | | ? | | Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim | | | | | Please provide your Indications for Use below. | | | ? | | Biodegradable Nitrile Powder Free Examination Glove, Green A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim A patient examination glove is a disposable device intended for medical purpose 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 Drug Permeation: The following chemicals have been tested with these gloves. | | | | | Chemotherapy Drugs | Concentration | Breakthrough Detection Time in Minutes | | | Amethopterine | 25.0 mg/ml | > 240 | | | Bleomycin Sulfate | 15.0 mg/ml | > 240 | | | Busulfan | 6.0 mg/ml | > 240 | | | Carboplatin | 10.0 mg/ml | > 240 | | | Carmustine (BCNU) | 3.3 mg/ml | 10.0 | | | Ciplastin | 1.0 mg/ml | > 240 | | | Cyclophosphamide (Cytoxan) | 20.0 mg/ml | > 240 | | | Cytarabine HCL (Cytosine) | 100.0 mg/ml | > 240 | | | Dacarbazine (DTIC) | 10.0 mg/ml | > 240 | | | Docetaxel (Taxotere) | 10.0 mg/ml | > 240 | | | Doxorubicin Hydrochloride | 2.0 mg/ml | > 240 | | | Epirubicin | 2.0 mg/ml | > 240 | | | Etoposide | 20.0 mg/ml | > 240 | | | Fludarabine | 25.0 mg/ml | > 240 | | | Fluorouracil | 50.0 mg/ml | > 240 | | | Gemcitabine | 38.0 mg/ml | > 240 | | | Idarubicin | 1.0 mg/ml | > 240 | | | Ifosfamide | 50.0 mg/ml | > 240 | | | Irinotecan | 20.0 mg/ml | > 240 | | | Mechlorethamine | 1.0 mg/ml | > 240 | | | Melphalan | 5.0 mg/ml | > 240 | | {4} | Methotrexate | 25.0 mg/ml | > 240 | | --- | --- | --- | | Mitomycin C | 0.5 mg/ml | > 240 | | Mitoxantrone | 2.0 mg/ml | > 240 | | Oxaliplatin | 5.0 mg/ml | > 240 | | Paclitaxel | 6.0 mg/ml | > 240 | | Rituximab | 10.0 mg/ml | > 240 | | Thiotepa | 10.0 mg/ml | 60.0 | | Topotecan | 1.0 mg/ml | > 240 | | Trisenox | 1.0 mg/ml | > 240 | | Vincristine Sulfate | 1.0 mg/ml | > 240 | | Vinorelbine | 10.0 mg/ml | > 240 | Please note that Carmustine and Thiotepa have extremely low permeation times of 10 minutes and 60 minutes respectively. Warning: Do not use with Carmustine and Thiotepa Simulated Gastric Acid Permeation Resistance Claim- Under the testing conditions of ASTM D6978-05, was found to have no breakthrough detected up to 240 minutes. Fentanyl Permeation Resistance Claim- Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2ml) was found to have no breakthrough detected up to 240 minutes. | Please select the types of uses. | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | | --- | --- | --- | | Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? | --- **Source:** [https://fda.innolitics.com/device/K262542](https://fda.innolitics.com/device/K262542) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com