Who can help prepare an FDA 510(k) submission like Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs?

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 Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs

Q: Who is the manufacturer of Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs?

Wrp Asia Pacific Sdn. Bhd. filed the 510(k) submission for Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs (K161823).

Q: What is the FDA product code for Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs?

KGO. It is classified under 21 CFR 878.4460 as a Class 1 device in the General, Plastic Surgery panel.

Q: What is the regulatory pathway for Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs?

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

K161823 · Wrp Asia Pacific Sdn. Bhd. · KGO · Jan 23, 2017 · General, Plastic Surgery

Device Facts

Record ID	K161823
Device Name	Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs
Applicant	Wrp Asia Pacific Sdn. Bhd.
Product Code	KGO · General, Plastic Surgery
Decision Date	Jan 23, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4460
Device Class	Class 1

Intended Use

A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The device has also been tested for use with chemotherapy drugs.

Device Story

Powder-free, sterile, hand-specific nitrile surgical glove; manufactured from synthetic rubber latex. Inner surface treated for smooth donning without powder. Used by operating room personnel to protect surgical wounds. Tested for permeation resistance against 12 chemotherapy drugs per ASTM D6978-05. Provides barrier protection; output is physical protection of the surgical site. Benefits include reduced risk of wound contamination and protection of personnel from chemotherapy drug exposure.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including ASTM D3577-09 (physical properties), ASTM D6978-05 (chemotherapy permeation), ASTM D5151-06 (watertightness), ASTM D6124-06 (powder content), and ISO 10993-10 (biocompatibility/irritation/sensitization).

Technological Characteristics

Material: Nitrile synthetic rubber. Form: Sterile, hand-specific, powder-free, micro-roughened texture. Dimensions: Min length 270mm, min thickness 0.10mm. Standards: ASTM D3577-09, D6978-05, D5151-06, D6124-06. Biocompatibility: ISO 10993-10. Connectivity: None. Energy source: None.

Indications for Use

Indicated for operating room personnel to protect surgical wounds from contamination. Tested for use with chemotherapy drugs per ASTM D6978-05.

Regulatory Classification

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.

Predicate Devices

Cardinal Health Sterile Neoprene Powder-free Surgical Gloves with Nitrile Coating (K153316)
SensiCare PI Surgical Gloves (K152428)

Related Devices

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 · Sentienx Sdn Bhd · Aug 18, 2023
K230217 — Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs · Grand Work Plastic Products Co., Ltd. · May 13, 2023
K210656 — ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs · Careplus (M) Sdn Bhd · Jun 24, 2021
K222058 — Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant · Wrp Asia Pacific Sdn. Bhd. · Oct 22, 2022
K214074 — Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs · Hartalega NGC Sdn. Bhd. · May 26, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 23, 2017 WRP Asia Pacific Sdn Bhd Sarala Jayaraman Regulatory Affairs Manager Lot 1, Jalan 3, Kaw Perusahaan Bandar Baru Salak Tinggi Sepang, 43900 MY Re: K161823 Trade/Device Name: Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: Class I Product Code: KGO, LZC Dated: December 15, 2016 Received: December 19, 2016 Dear Sarala Jayaraman: 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. 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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely. Michael J. Ryan -S for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page. ### 510(k) Number (if known) K161823 ### Device Name Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs ## Indications for Use (Describe) A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. 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 Drug | Concentration | Breakthrough Detection Time in Minutes | |----------------------------|---------------|----------------------------------------| | *Carmustine (BCNU) | 3.3mg/ml | 30.4 | | Cisplatin | 1.0mg/ml | > 240 | | Cyclophosphamide (Cytoxan) | 20.0mg/ml | > 240 | | Dacarbazine | 10.0mg/ml | > 240 | | Doxorubicin Hydrochloride | 2.0mg/ml | > 240 | | Etoposide (Toposar) | 20.0mg/ml | > 240 | | Fluorouracil | 50.0mg/ml | > 240 | | Ifosfamide | 50.0mg/ml | > 240 | | Mitoxantrone | 2.0mg/ml | > 240 | | Paclitaxel (Taxol) | 6.0mg/ml | > 240 | | *Thiotepa | 10.0mg/ml | 59.0 | | Vincristine Sulfate | 1.0mg/ml | > 240 | CAUTION: Testing showed an average breakthrough time of 30.4 minutes for Carmustine and an average breakthrough time of 59.0 minutes for Thiotepa. Type of Use (Select one or both, as applicable) [] Prescription Use (Part 21 CFR 801 Subpart D) 区 Over-The-Counter Use (21 CFR 801 Subpart C) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) {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}------------------------------------------------ #### 1.0 Submitter: | Name: | Sarala Devi Jayaraman | |------------|------------------------------------------------------------------------------------------------------------------------------------------| | Address: | WRP Asia Pacific Sdn Bhd Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA | | Phone No.: | +60 3 8706 1486 | | Fax No.: | +60 3 8706 1485 | Date of Summary Prepared: 12 January 2017 #### 2.0 Name of the modified device Identification: Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs 510(k) Number: K161823 Common Name: Surgical Gloves Classification Name: Surgeon's Gloves (21 CFR 878.4460 product code KGO) Patient Examination Gloves Specialty (21 CFR 880.6250 product code LZC) ### 3.0 Identification of The Legally Marketed Devices that equivalency is claimed: | | Predicate 1 | Predicate 2 | |------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------| | Manufacturer | Cardinal Health 200, LLC | Medline Industries, Incorporated | | Device name | Cardinal Health™ Sterile Neoprene Powder-free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow) | SensiCare PI Surgical Gloves | | 510(k) Number | K153316 | K152428 | | Regulatory Class | I | I | | Product Code | KGO, LZC | KGO, LZC | #### 4.0 Description of The Device: Powder Free Nitrile Surgical Glove, Sterile meets all the requirements of ASTM standard D3577-09, D6978-05 and FDA 21 CFR 878.4460. The powder free nitrile surgical glove is manufactured from synthetic rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is hand specific. The physical properties of glove i.e. tensile strength meet ASTM standard D3577-09. {5}------------------------------------------------ ### 5.0 Intended Use of the Device: A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The device has also been tested for use with chemotherapy drugs. 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 Drug | Concentration | Breakthrough Detection Time in Minutes | | *Carmustine (BCNU) | 3.3mg/ml | 30.4 | | Cisplatin | 1.0mg/ml | > 240 | | Cyclophosphamide (Cytoxan) | 20.0mg/ml | > 240 | | Dacarbazine | 10.0mg/ml | > 240 | | Doxorubicin Hydrochloride | 2.0mg/ml | > 240 | | Etoposide (Toposar) | 20.0mg/ml | > 240 | | Fluorouracil | 50.0mg/ml | > 240 | | Ifosfamide | 50.0mg/ml | > 240 | | Mitoxantrone | 2.0mg/ml | > 240 | | Paclitaxel (Taxol) | 6.0mg/ml | > 240 | | *Thiotepa | 10.0mg/ml | 59.0 | | Vincristine Sulfate | 1.0mg/ml | > 240 | CAUTION: Testing showed an average breakthrough time of 30.4 minutes for Carmustine and an average breakthrough time of 59.0 minutes for Thiotepa. ### 6.0 Summary of the Technological Characteristics of the Device: The Powder Free Nitrile Surgical Glove, Sterile are summarized with the following technological characteristics compared to ASTM D3577 or equivalent standards as shown in Table 1 Compliant to chemotherapy claim whereby glove thickness and length meets minimal thickness of 0.10 mm and minimal length of 270 respectively. {6}------------------------------------------------ ## Table 1 | CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | | |-------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | Predicate 1 | Predicate 2 | Current | | Manufacturer(s) | | Cardinal Health 200, LLC | Medline Industries, Incorporated | WRP Asia Pacific Sdn Bhd | | 510(k) Number | | K153316 | K152428 | K161823 | | Intended use | - | A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber 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. | The SensiCare PI surgeon's glove is a disposable device made of synthetic rubber 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. Warning: Do not use with Carmustine and Thiotepa | A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber 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. *CAUTION: Testing showed an average breakthrough time of 30.4 minutes for Carmustine and an average breakthrough time of 59.0 minutes for Thiotepa. | | Material | ASTM D3577- 09 | Synthetic Neoprene Polymer coated with Nitrile | Synthetic Polyisoprene | Nitrile | | Color | - | Yellow | Cream colored. Contains a blend of three colorants (naphthos AS red, azo yellow and carbon black) | Natural | | Texture | | | - | Micro roughened | | CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | | | | | | | | | 510(k) Number | ASTM D3577-09 | Predicate 1 K153316 | Predicate 2 K152428 | Current K161823 | | Dimensions | ASTM D3577-09 | Meets | Meets | Meets | | Length | ASTM D3577-09 | Min 270mm | Min 270mm | Min 270mm | | Width | ASTM D3577-09 | Meets | Meets 5 ½ : 70±6mm 6 : 76±6mm 6 ½ : 83±6mm 7 : 89±6mm 7 ½ : 95±6mm 8 : 102±6mm 8 ½ : 108±6mm 9 : 114±6mm | Meets 5 ½ : 70±6mm 6 : 76±6mm 6 ½ : 83±6mm 7 : 89±6mm 7 ½ : 95±6mm 8 : 102±6mm 8 ½ : 108±6mm 9 : 114±6mm | | Thickness - Finger - Palm - Cuff | ASTM D3577-09 | Meets | Meets Min 0.10mm Min 0.10mm Min 0.10mm | Meets Min 0.10mm Min 0.10mm Min 0.10mm | | Physical Properties Before Aging Tensile Strength : Ultimate Elongation : Stress at 500% Elongation : | ASTM D3577-09 | Meets | Meets 7MPa min 650% min 7.0MPa min | Meets 7MPa min 650% min 7.0MPa min | | Physical Properties After Aging Tensile Strength : Ultimate Elongation : | ASTM D3577-09 | Meets | Meets 12MPa min 490% min | Meets 12MPa min 490% min | | Watertight (1000ml) | ASTM D5151-06 | Meets 21CFR 800.20 & ASTM D3577 requirements of AQL 1.5 | Meets 21 CFR 800.20 and ASTM D3577 when tested in accordance with ASTM D5151 Inspection Level 1, AQL 1.5 | Meets 21 CFR 800.20 and ASTM D3577 when tested in accordance with ASTM D5151 Inspection Level 1, AQL 1.5 | | Powder Free | ASTM D6124-06 (≤ 2 mg/glove) | Meets requirements of ≤2.0 mg/glove for Powder-Free designation per ASTM D3577 | <2mg of residual powder when tested in accordance with ASTM D3577 | Meets requirements of ≤2.0 mg/glove for Powder-Free designation per ASTM D3577 | | CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | | | | | Predicate 1 | Predicate 2 | Current | | 510(k) Number | | K153316 | K152428 | K161823 | | Chemotherapy Drug Permeation Test | ASTM D6978-05 | | | | | Test Chemotherapy Drug | Concentration | Minimum Breakthrough Detection Time (min) | | | | *Carmustine (BCNU) | 3.3mg/ml | 60.1 | 10.1 | 30.4 | | Cisplatin | 1.0mg/ml | > 240 | > 240 | > 240 | | Cytarabine | 100.0mg/ml | | > 240 | - | | Cyclophosphamide (Cytoxan) | 20.0mg/ml | > 240 | > 240 | > 240 | | Dacarbazine | 10.0mg/ml | - | > 240 | > 240 | | Doxorubicin Hydrochloride | 2.0mg/ml | > 240 | > 240 | > 240 | | Etoposide (Toposar) | 20.0mg/ml | > 240 | > 240 | > 240 | | Fluorouracil | 50.0mg/ml | > 240 | > 240 | > 240 | | Ifosfamide | 50.0mg/ml | - | > 240 | > 240 | | Methotrexate | 25.0mg/ml | > 240 | > 240 | - | | Mitoxantrone | 2.0mg/ml | - | > 240…