510(k) Report

Devices descending from K012602

28 later devices reach Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid Earloop Face… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100846Imc Surgical Face MaskInternational Medsurg Connection20103—
+1K092580Tidi FacemaskTidi Products,Llc20109—
+1K050689Surgical Face MaskChina Surgical Dressings Center Co., Ltd.20050—
+1K040333Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach) with or Without…Valumax Intl., Inc.200421—
+1K023755Winner Ear Loop Procedure Mask, Tie-on Surgical Mask & Ear Loop Procedure Mask with ShieldWinner Industries (Shenzhen) Co., Ltd.20030—
+2K212375Disposable Medical Surgical MaskJiangxi Bestgrand Health Technology Co., Ltd.20220—
+2K202954Disposable Surgical MaskXiamen Probtain Medical Techology Co., Ltd.20210—
+2K210429Disposable Surgical Face MaskJiangxi Heying Pharmaceutical Co., Ltd.20210—
+2K141875Pasture 60S Surgical MaskPasture Pharma Pte, Ltd.20153—
+2K093179Medical Surgical Mask (HH1001), Respiratory Mask (HH1002)H&H Research Company20103—
+2K100800Tidi FacemaskTidi Products,Llc20100—
+2K061864Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540; with Shield, Model 1560Dukal Corp.20066—
+2K051291Non-Sterile Surgical MaskA.R. Medicom, Inc.2005205
+3K212273Cross Protection ResQ300 Plus Surgical Face MaskCross Protection (M) Sdn Bhd20220—
+3K203425Surgical MaskBdc Dental Corporation, Ltd.20210—
+3K202577Medical Surgical Mask-Model MP002-5, MP002-6Jiangmen Sure&Me Medical Product Co., Ltd.20210—
+3K202139Medical surgical maskGuangdong Kingfa Sci. & Tech.Co., Ltd.20201—
+3K152197Skypro, SP01 MaskSkypro Medical Supplies Company20162—
+3K111559Surgical MasksShanghai Neo-Medical Import & Export Co., Ltd.20114—
+3K110027Surgical Face Mask; Surgical Face MaskAngeline Group, Ltd.20110—
+3K070407Dukal Surgical Face Mask Tie, Ear Loop, with Shield Yellow & White; Anti Fog Tie, Loop…Dukal Corp.20070—
+4K213450Medical surgical mask (Black mask, Level 1 and Level 3)Guangdong Kingfa Sci. & Tech.Co., Ltd.20220—
+4K202255Skypro, SP02 Mask (3)Skypro Medical Supplies Company20210—
+4K203646Disposable Medical Face MaskGuangzhou Mei YI Kang Medical Technology Co., Ltd.20210—
+4K201137Asept Surgical Face MaskPfm Medical, Inc.20203—
+5K203174Disposable Medical MaskDong Guan Kinyet Metal Products Co., Ltd.20210—
+5K203200Disposable Medical Surgical Face MaskGuangdong Haiou Medical Apparatus Co., Ltd.20211—
+6K210643Disposable Surgical Face MaskShandong Zhushi Pharmaceutical Group Co., Ltd.20210—