← Product Code [KGO](/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO) · K222993 # Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs (K222993) _Sentienx Sdn Bhd · KGO · Aug 18, 2023 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K222993 ## Device Facts - **Applicant:** Sentienx Sdn Bhd - **Product Code:** [KGO](/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO.md) - **Decision Date:** Aug 18, 2023 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4460 - **Device Class:** Class 1 - **Review Panel:** General, Plastic Surgery ## Intended Use A powder-free surgeon's glove is a device made of synthetic elastomer that is intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs and ASTM D6355-07, Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves. ## Device Story Synthetic elastomer powder-free surgical gloves; designed for use by operating room personnel to protect surgical wounds from contamination. Gloves provide barrier protection during handling of chemotherapy agents. Tested per ASTM D6978 for permeation resistance against various chemotherapy drugs; tested per ASTM D6355-07 for low dermatitis potential. Output is physical barrier protection; healthcare providers use gloves during surgical procedures and chemotherapy administration to prevent patient contamination and protect the wearer from chemical exposure. Benefits include reduced risk of surgical site infection and chemical exposure. ## Clinical Evidence Bench testing only. Permeation testing performed per ASTM D6978 for 13 (Green) and 32 (White) chemotherapy drugs. Human Repeat Insult Patch Testing (HRIPT) performed per ASTM D6355-07 to support low dermatitis potential claim. ## Technological Characteristics Synthetic elastomer; powder-free; surgical glove form factor. Tested per ASTM D6978 (chemotherapy permeation) and ASTM D6355-07 (dermatitis potential). ## Regulatory Identification A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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}------------------------------------------------ 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. August 18, 2023 Sentienx Sdn Bhd % David Lim Executive Director TG Medical USA (INC) 165 N. Aspen Ave. Azusa, California 91702 ### Re: K222993 Trade/Device Name: Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO, LZC, OPJ Dated: August 15, 2023 Received: August 15, 2023 ## Dear David Lim: 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 (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, # Bifeng Qian -S BiFeng Qian, M.D., 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}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K22993 #### Device Name Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs #### Indications for Use (Describe) A powder-free surgeon's glove is a device made of synthetic elastomer that is intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs and ASTM D6355-07, Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves. Chemotherapy Drugs Permeation The following drugs have been tested with these gloves | No. | Chemotherapy Drugs | Concentration | Breakthrough Detection Time in Minutes | |-----|---------------------|---------------|----------------------------------------| | 1. | Carmustine | 3.3 mg/ml | 7.7 | | 2. | Cisplatin | 1.0 mg/ml | >240 | | 3. | Cyclophosphamide | 20.0 mg/ml | >240 | | 4. | Dacarbazine | 10.0 mg/ml | >240 | | 5. | Doxorubicin HCI | 2.0 mg/ml | >240 | | 6. | Etoposide | 20.0 mg/ml | >240 | | 7. | Fluorouracil | 50.0 mg/ml | >240 | | 8. | Ifosfamide | 50.0 mg/ml | >240 | | 9. | Methotrexate | 25.0 mg/ml | >240 | | 10. | Mitomycin C | 0.5 mg/ml | >240 | | 11. | Paclitaxel (Taxol) | 6.0 mg/ml | >240 | | 12. | Thiotepa | 10.0 mg/ml | 11.4 | | 13. | Vincristine Sulfate | 1.0 mg/ml | >240 | Warning: The permeation times for Carmustine and Thiotena are extremely low with permeation times of 7,7 minutes and 11.4 minutes respectively. Do not use with Carmustine or Thiotepa. 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. 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}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K22993 #### Device Name Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs #### Indications for Use (Describe) A powder-free surgeon's glove is a device made of synthetic elastomer that is intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs and ASTM D6355-07, Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves. Chemotherapy Drugs Permeation The following drugs have been tested with these gloves | No. | Chemotherapy Drugs | Concentration | Breakthrough Detection Time in Minutes | |-----|----------------------|---------------|----------------------------------------| | 1. | Carmustine | 3.3 mg/ml | 11.9 | | 2. | Cisplatin | 1.0 mg/ml | >240 | | 3. | Cyclophosphamide | 20.0 mg/ml | >240 | | 4. | Dacarbazine | 10.0 mg/ml | >240 | | 5. | Doxorubicin HCI | 2.0 mg/ml | >240 | | 6. | Etoposide | 20.0 mg/ml | >240 | | 7. | Fluorouracil | 50.0 mg/ml | >240 | | 8. | Ifosfamide | 50.0 mg/ml | >240 | | 9. | Methotrexate | 25.0 mg/ml | >240 | | 10. | Mitomycin C | 0.5 mg/ml | >240 | | 11. | Paclitaxel (Taxol) | 6.0 mg/ml | >240 | | 12. | Thiotepa | 10.0 mg/ml | 12.3 | | 13. | Vincristine Sulfate | 1.0 mg/ml | >240 | | 14. | Bleomycin Sulfate | 15.0 mg/ml | >240 | | 15. | Busulfan | 6.0 mg/ml | >240 | | 16. | Carboplatin | 10.0 mg/ml | >240 | | 17. | Cytarabine HCI | 100.0 mg/ml | >240 | | 18. | Cytovene | 10.0 mg/ml | >240 | | 19. | Daunorubicin HCI | 5.0 mg/ml | >240 | | 20. | Docetaxel | 10.0 mg/ml | >240 | | 21. | Epirubicin HCI | 2.0 mg/ml | >240 | | 22. | Fludarabine | 25.0 mg/ml | >240 | | 23. | Gemcitabine (Gemzar) | 38.0 mg/ml | >240 | | 24. | Idarubicin HCI | 1.0 mg/ml | >240 | | 25. | Irinotecan | 20.0 mg/ml | >240 | | 26. | Mechlorethamine HCI | 1.0 mg/ml | >240 | | 27. | Melphalan | 5.0 mg/ml | >240 | | 28. | Mitoxantrone | 2.0 mg/ml | >240 | | 29. | Oxaliplatin | 5.0 mg/ml | >240 | | 30. | Rituximab | 10.0 mg/ml | >240 | | 31. | Trisenox | 1.0 mg/ml | >240 | | 32. | Vinorelbine | 10.0 mg/ml | >240 | {4}------------------------------------------------ Warning : The permeation times for Carmustine and Thiotepa are extremely low with permeation times of 11.9 minutes and 12.3 minutes respectively. Do not use with Carmustine or Thiotepa. 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. 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." --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K222993](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K222993) **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. 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